Method and instrument for treating obesity

ABSTRACT

A gastroscopic method and instrument for treating obesity of a patient, using a device adapted to stretch a part of the stomach wall of said patient. The method comprises the steps of: inserting the device into the stomach through the esophagus, placing the device in contact with the stomach wall, and fixating the device to the stomach wall such that the device can stretch a part of the stomach wall.

TECHNICAL FIELD

The present invention relates to a device treating obesity.

BACKGROUND

In the past, obese patients have been treated by gastric reductionsurgery to restrict the food intake of the patient. At present, twogastric restriction procedures for treating obesity are most commonlyperformed, namely Adjustable Gastric Banding (AGE) and Vertical BandedGastroplasty (VBG).

In AGE, a constricting band is placed completely around an obesepatient's surgically intact stomach near the upper end thereof, justbelow the junction of stomach and esophagus, to restrict the food intakeof the patient. As the band constricts the stomach, a small gastricpouch is formed above the band and a reduced permanent stoma in thestomach. The idea being that a small amount of food filling the smallpouch causes the patient to sense fullness, i.e., satiety. Examples ofAGE are disclosed in U.S. Pat. No. 4,592,339 and European Patent No.0611561,

In VBG, typically the stomach is stapled vertically with four rows oflinear staples, which compartmentalize the stomach into an elongateproximal smaller compartment adjacent the esophagus and a distal largercompartment, so that the volume of the smaller compartment is about 10%of the volume of the stomach. A circular hole is punched-out in thestomach at the lower end of the rows of linear staples and severalcircular rows of staples are placed on the stomach around the circularhole. A hand is placed through the circular hole and is secured aroundthe stomach, whereby the band defines a narrow outlet opening from thesmaller compartment into the larger compartment of the stomach. Oncesecured, the band prevents the stomach from stretching at the outletopening, which results in that the outlet opening over time maintainsits initial small diameter. Food that the patient takes in is held up inthe smaller compartment causing the sensation of fullness. Then, thefood empties slowly through the outlet opening into the largercompartment where digestion takes place normally. Examples of VBG aredisclosed in U.S. Pat. Nos. 5,345,949 and 5,549,621.

There are few complications associated with AGB and VBG. However, it isimportant that the patient very carefully chews food completely beforeswallowing it, so that food pieces collected in the smaller compartmentof the stomach are able to pass through the narrow outlet opening of thesmaller compartment. If food pieces were stuck in the outlet opening itmight cause the patient to vomit and feel sick. In such a case thepatient should have to visit a doctor or nurse. Another complicationassociated with AGB and VBG is that the patient may suffer from acidstomach reflux at night.

The use of electrical stimulation of the stomach wall to cause thepatient to feel satiety has also been used.

SUMMARY

A gastroscopic method of treating obesity of a patient using a deviceadapted to stretch a part of the stomach wall of the patient isprovided. The method comprises the steps of: inserting the device intothe stomach of the patient through the esophagus, placing the device incontact with the stomach wall, fixating the device to the stomach wallsuch that the device can stretch a part of the stomach wall.

According to one embodiment the step of fixating the device comprisesthe steps of: fixating a first portion of the device to a first part ofthe stomach wall, and fixating a second portion of the device to asecond part of the stomach wall. The step of fixating the first andsecond portion of the device could comprise the step of invaginating thefirst and second portion with stomach to stomach sutures or staples.

According to one embodiment the method comprises the additional steps ofplacing a second device adapted to stretch a portion of the stomach wallin contact with the stomach, fixating the second device to the stomachwall, stretching a first portion of the stomach wall using the firstdevice, and stretching a second part of the stomach wall using thesecond device.

According to one embodiment the stretching of the second portioncomprises the step of: time delaying stretching the second part, with apredetermined time delay.

The method according to any of the embodiment could further comprise thesteps of: inserting a gastroscope into the stomach of the patient,pushing a portion of the stomach wall to prepare a pouch on the outsideof the stomach, inserting the device into the pouch, placed on theinside of the stomach wall, suturing or stapling to enclose the devicein the pouch before or after the insertion of the device into the pouch.

According to one embodiment the method further comprises the steps of:inserting a gastroscope into the stomach of the patient, pulling aportion of the stomach wall to prepare a pouch on the inside of thestomach, creating a hole in the stomach wall into the pouch, insertingthe device into the pouch, through the hole in the stomach wall,suturing or stapling the pouch, before or after the insertion of thedevice through the hole.

The method could further comprise the step of placing a transferringmember from the device to a control unit, which could be a fluidtransferring member and/or a member adapted to transfer electricalpower.

The method could further comprise the step of placing a control unit,which can be placed subcutaneously in the patient.

According to one embodiment the step of placing a transferring memberfrom the device to a control unit comprises the steps of cutting anopening in the abdomen of the patient, connecting the transferringmember to the control unit, inserting the control unit into the openingin the skin of the patient, and fixating the control unitsubcutaneously.

According to one embodiment the method further comprises the step ofplacing a transferring member from the device to a control unitcomprises the steps of: cutting an opening in the abdomen of thepatient, connecting the transferring member to the control unit,inserting the control unit into the opening in the skin of the patient,to be placed in the abdominal cavity. The step of placing the controlunit could comprise the steps of: fixating the control unit to theabdominal wall.

Stretching

According to one embodiment of the method according to any of theembodiments the method comprises the additional step of postoperativelyand non-invasively regulating the device to stretch a portion of thestomach wall to affect the appetite of the patient.

The step of postoperatively and non-invasively regulating the device tostretch a part of the stomach wall comprises the step of increasing thedistance between the first part of the stomach wall and the second partof the stomach wall.

According to one embodiment the step of regulating the device isperformed from outside the patient's body, whereas according to otherembodiments the method step of regulating the device comprisesregulating the device by the implantable control unit from inside thebody.

According to one embodiment the step of regulating the device comprisesfrom time to time regulate different devices to at a first time stretcha first portion of the stomach wall and at a second time stretch asecond portion of the stomach wall.

According to one embodiment the method comprises placing two or moredevices in contact with the stomach and from time to time regulatedifferent device to stretch a part of the stomach wall.

The step of placing a device in contact with the stomach could compriseplacing a device adapted to have a variable volume in contact with thestomach, the volume could be variable through at least one moveable wallportion, which in turn could be at least one elastic wall portion.

The device according to any of the embodiments could have an essentiallyround shape, or an egg shape.

The device could further comprise a subcutaneous switch, and the methodcould further comprise pressing the switch for manually andnon-invasively regulating the device.

According to one embodiment the step of regulating the device comprisesthe step of moving a fluid from a reservoir to the device.

According to one embodiment the device could comprise a pump, and themethod could comprise the step of; pumping a fluid from the reservoir tothe device to stretch the stomach wall.

The step of moving a fluid from a reservoir to the device could comprisethe step of moving a wall portion of the reservoir.

The step of regulating the device could comprise the step of manuallypressing the reservoir, which could be placed subcutaneously or in theabdomen.

Mechanical

According to one embodiment the step of increasing the distance betweenthe first part of the stomach wall and the second part of the stomachwall comprises the step of moving fluid into a chamber having a variablevolume.

Automatic

According to one embodiment the step of placing a device in contact withthe stomach comprises placing a device adapted to have a variable volumein contact with the stomach.

The device could be adapted to have a variable volume comprising atleast one moveable wall portion, which could comprise at least oneelastic wall portion.

The device could have an essentially round shape, or an essentiallyegg-like shape.

The device could further comprise a subcutaneous switch, and the methodcould further comprise pressing the switch for non-invasively regulatingthe device.

The step of regulating the device could comprise the step of moving afluid from a reservoir to the device, which in turn could comprise thesteps of: operating a pumping device, the pumping device moving thefluid from the reservoir to the device, and the device expanding involume and thereby stretching the portion of the stomach wall.

The method could further comprise the step of the fluid flowing backfrom the device to the reservoir, thereby releasing the stretching ofthe stomach wall.

According to one embodiment the method could comprise the step of:sensing a variable using an implantable sensor, interpreting the sensedvariable and using the interpreted variable to control the device.

According to another embodiment the step of controlling the devicecomprises the steps of: operating a pumping device, for moving the fluidfrom a reservoir to the device, and the device expanding in volume andthereby stretching the portion of the stomach wall.

According to one embodiment the method comprises the step of the fluidflowing back from the device to the reservoir thereby releasing thestretching of the stomach wall.

The step of sensing a variable could comprise the step of sensing avariable connected to the food intake of the patient, which step couldcomprise the step of sensing a variable connected to the food intake ofthe patient is resulting in a increased stretching of the stomachportion, and thereby feeling of satiety by the patient.

Mechanical

According to one embodiment the step of increasing the distance betweenthe first part of the stomach wall and the second part of the stomachwall comprises the step of moving fluid into a chamber having a variablevolume.

The method could further comprise the step of moving fluid from areservoir to the chamber having a variable volume. The step of moving afluid from a reservoir to the device could comprise the steps of:operating a pumping device, the pumping device moving the fluid from thereservoir to the device, and the device expanding in volume and therebystretching the portion of the stomach wall.

According to one embodiment the step of operating the pumping devicecomprises the step of operating the pumping device using a wirelessremote control.

According to one embodiment the method further comprises the step of thefluid flowing back from the device to the reservoir thereby releasingthe stretching of the stomach wall.

According to one embodiment the step of increasing the distance betweenthe first part of the stomach wall and the second part of the stomachwall comprises the step of operating a motor adapted increase thedistance between the first part of the stomach wall and the second partof the stomach wall, thereby stretching a portion of the stomach wall.Operating the motor could comprise the step of operating the motor usinga wireless remote control.

According to one embodiment the method further comprises the step of:sensing a variable using an implantable sensor, interpreting the sensedvariable, using the interpreted variable to control the device.

According to one embodiment the method comprises the steps of: operatinga it) pumping device, the pumping device moving the fluid from areservoir to the chamber, and the chamber being filled with the fluidincreasing the distance between the first part of the stomach wall andthe second part of the stomach wall and thereby stretching the portionof the stomach wall.

According to one embodiment the method further comprises the step of thefluid flowing hack from the device to the reservoir thereby releasingthe stretching of the stomach wall.

According to one embodiment the step of sensing a variable comprises thestep of sensing a variable connected to the food intake of the patient.

According to one embodiment the method further comprises the step of:sensing a variable using an implantable sensor, interpreting the sensedvariable, using the interpreted variable to control the device. The stepof sensing a variable could comprise the step of sensing a variableconnected to the food intake of the patient.

The step of increasing the distance between the first part of thestomach wall and the second part of the stomach wall could comprise thestep of operating a mechanical device adapted increase the distancebetween the first part of the stomach wall and the second part of thestomach wall, thereby stretching a portion of the stomach wall.

According to one embodiment the device comprises mechanical membersadapted to move for stretching a portion of the stomach wall between thefirst and second part of the stomach wall. The mechanical members couldbe moving for stretching a portion of the stomach wall using the motor.

According to one embodiment the step of stretching a portion of thestomach wall comprises the step of operating at least one mechanicaldevice for stretching a portion of the stomach wall.

According to one embodiment the method comprises the step ofinvaginating the mechanical device in the stomach wall with stomach tostomach sutures.

According to one embodiment the method comprises the step of expandingthe mechanical device in the invaginated stomach wall to stretch thestomach wall.

According to one embodiment the method comprises a motor, expanding thestomach wall, according to another embodiment the method comprise amemory metal, expanding the stomach wall.

According to another embodiment the method comprises a hydraulicallycontrolled mechanical device, expanding the stomach wall.

Placing

According to one embodiment the step of placing a device comprisesplacing the device in connection with the stomach wall, on the outsidethereof, which could comprise the step of

placing the device in the stomach fundus wall of the patient.

The step of placing a device could comprise the step of placing thedevice in connection with the stomach wall, on the inside thereof, whichcould comprise the step of

placing the device in the stomach fundus wall of the patient.

Fixation

The step of fixating the at least one device comprises suturing orstapling the at least one device to the stomach wall.

The step of fixating the at least one device could comprise invaginatingin the stomach wall with stomach-to-stomach sutures or staples, in otherembodiments the step of fixating the at least one device could compriseplacing a mesh adapted to be fixated to the stomach wall by means offibrotic tissue.

The mesh could be additionally supported by sutures or staples and couldcomprise a structure adapted to promote the growth in of human tissue,such as a net like structure.

An additional method is provided, the method comprising the steps of:creating a hole in the stomach wall; introducing the stretching deviceinto the stomach by means of a instrument; moving the device through thehole and placing it on the outside of the stomach wall; creating a pouchof a portion of the stomach wall inside the stomach cavity, with thedevice placed against the outside of the stomach wall; invaginating thedevice in the pouch to the stomach wall; and sealing the hole,preferably with sutures or staples.

An additional method is provided, the method comprising the steps of:creating a hole in the stomach wall; creating, by means of theinstrument, a pouch of a portion of the stomach wall on the inside ofthe stomach cavity; introducing the device into the stomach by means ofthe instrument; moving the device through the hole and placing it on theoutside of the stomach wall; introducing the device by means of theinstrument into the pouch; invaginating the device to the stomach wall;and sealing the hole, preferably with sutures or staples.

According to one embodiment the method, further comprises providing adevice for regulating the stretching device from the outside of thepatient's body; and operating the device to regulate the device.

According to another embodiment the method further comprises the stepsof: cutting the skin of the patient, inserting a tube into the abdominalcavity of the patient, connecting the tube to the stretching device,filling the device with fluid injected through the tube.

According to another embodiment the method further comprises the stepsof subcutaneously placing an injection port and connecting the tube tothe injection port.

According to another embodiment the method further comprises the step ofproviding a tube connected to the stretching device through the hole andfurther up to the abdominal wall or passing through the abdominal wall.

According to another embodiment the method further comprises the stepsof: cutting the skin of the patient, receiving the tube from theabdominal cavity of the patient, connected to the stretching device, andfilling the device with fluid injected through the tube.

According to another embodiment the method the method further comprisesthe steps of: subcutaneously placing an injection port, and connectingthe tube to the injection port.

Instrument

An instrument for placing a device adapted to stretch a part of thestomach wall of a patient in connection with the stomach wall is furtherprovided. The instrument comprises: a holding member adapted toreleaseably hold the device, an insertion member adapted to insert thedevice through the stomach wall, and a fixating member, adapted toassist in the fixation of the device to the stomach wall, on the outsidethereof.

The instrument could further comprise a cutting member for cutting ahole in the stomach wall, an optical member for viewing in the area ofthe stomach. The fixation member could be adapted for suturing thedevice to the stomach wall, on the inside thereof, or for stapling thedevice to the stomach wall, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach sutures, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach staplers, on the inside thereof, however theinstrument could be adapted to perform the method from the outsidethereof.

The instrument could further comprise a special holding device, whichcould comprise a special holding device adapted to hold the stomachusing vacuum or using mechanical holding members.

A surgical or laparoscopic method of treating obesity of a patient usinga device adapted to stretch a portion of the stomach wall of the patientis provided. The method comprises the steps of cutting a hole in theabdominal wall of the patient, dissecting an area around the stomach,placing the device in contact with the stomach, and fixating, direct orindirect, through invagination of the stomach wall the device to thestomach wall such that the device can stretch a portion of the stomachwall.

According to one embodiment the method the step of fixating the devicecomprises the steps of fixating a first portion of the device to a firstpart of the stomach wall, and fixating a second portion of the device toa second part of the stomach wall, wherein the first and second portionof the device is fixated, such that the device is adapted to stretch aportion of the stomach wall between the first and second part of thestomach wall.

According to another embodiment, the device is a first device, and themethod comprises the additional steps of: fixating direct or indirectthrough invagination of the stomach wall a second device adapted tostretch a part of the stomach wall in contact with the stomach, fixatingthe second device to the stomach wall, stretching a first portion of thestomach wall using the first device, and stretching a second portion ofthe stomach wall using the second device.

According to another embodiment the method comprises the additional stepof postoperatively and non-invasively regulating the device to stretch aportion of the stomach wall to affect the appetite of the patient.

A surgical or laparoscopic method of treating obesity of a patient usinga device adapted to stretch a portion of the stomach wall of the patientis further provided. The method comprises the steps of: inserting aneedle or tube like instrument into the abdomen of the patients body,using the needle or tube like instrument to fill the patient's body withgas, placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars in thepatient's body, inserting at least one dissecting tool through one ofthe at least two laparoscopic trocars, dissecting an area of thestomach, introducing a device into the abdominal cavity, placing thedevice on the outside of the stomach wall, engaging the stomach wall.

According to another embodiment the method comprises the step ofpostoperatively and noninvasively regulating the device to stretch apart of the stomach wall comprises the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall.

According to another embodiment the step of regulating the device isperformed from outside the patient's body.

According to another embodiment the step of regulating the devicecomprises from time to time regulate different device to at a first timestretch a first portion of the stomach wall and at a second time stretcha second portion of the stomach wall.

According to another embodiment the method comprises placing two or moredevice in contact with the stomach and from time to time regulatedifferent device to stretch a portion of the stomach wall. The step offixating the first and second portion of the device could furthercomprise the step of invaginating the first and second portion withstomach to stomach sutures or staplers.

According to another embodiment, the device further comprises animplantable control unit, wherein the method step of regulating thedevice comprises regulating the device by the implantable control unitfrom inside the body.

According to another embodiment the stretching of the second portioncomprises the step of:

time delaying stretching the second part, with a predetermined timedelay.

Manual

According to another embodiment the step of placing a device in contactwith the stomach comprises placing a device adapted to have a variablevolume in contact with the stomach, which could be regulated by means ofat least one moveable wall portion, which in turn could be an elasticwall portion. The device could have an essentially round shape, or eggshape.

According to another embodiment the device comprises a subcutaneousswitch, and the method further comprises pressing the switch farmanually and non-invasively regulating the device. Regulating the devicecould comprise the step of moving a fluid from a reservoir to thedevice.

According to another embodiment the device further comprises a pump, andthe method further comprises the step of; pumping a fluid from thereservoir to the device to stretch the stomach wall.

According to another embodiment the step of moving a fluid from areservoir to the device comprises the step of moving a wall portion ofthe reservoir, which could be done through the step of manually pressingthe reservoir.

The reservoir, according to any of the embodiments could be placedsubcutaneously or in the abdomen.

Mechanical

According to another embodiment the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall comprises the step of moving fluid into a chamber having avariable volume.

Automatic

According to another embodiment the step of placing a device in contactwith the stomach comprises placing a device adapted to have a variablevolume in contact with the stomach.

The device adapted to have a variable volume could comprise at least,one moveable wall portion, which in turn could be an elastic wallportion.

The device according to any of the embodiments could comprise asubcutaneous switch, and the method could further comprise pressing theswitch for noninvasively regulating the device.

According to another embodiment the step of regulating the devicecomprises the step of moving a fluid from a reservoir to the device. Thestep of moving a fluid from a reservoir to the device could comprise thesteps of: operating a pumping device, for moving the fluid from thereservoir to the device, and the device expanding in volume and therebystretching the portion of the stomach wall.

According to another embodiment the method further comprises the step ofthe fluid flowing back from the device to the reservoir, therebyreleasing the stretching of the stomach wall.

According to another embodiment the method further comprises the stepof: sensing a variable using an implantable sensor, interpreting thesensed variable, using the interpreted variable to control the device.

According to another embodiment the step of controlling the devicecomprises the steps of: operating a pumping device, for moving the fluidfrom a reservoir to the device, and the device expanding in volume andthereby stretching the portion of the stomach wall.

According to another embodiment the method further comprises the step ofthe fluid flowing back from the device to the reservoir therebyreleasing the stretching of the stomach wall.

The step of sensing a variable could comprise the step of sensing avariable connected to the food intake of the patient, which could resultin an increased stretching of the stomach portion, and thereby thefeeling of satiety by the patient.

Mechanical

According to another embodiment the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall could comprise the step of moving fluid into a chamberhaving a variable volume.

According to another embodiment the step moving fluid into a chambercomprises the step of moving fluid from a reservoir to the chamberhaving a variable volume.

According to another embodiment the step of moving a fluid from areservoir to the device comprises the steps of: operating a pumpingdevice, the pumping device moving the fluid from the reservoir to thedevice, and the device expanding in volume and thereby stretching theportion of the stomach wall.

According to another embodiment the step of operating the pumping devicecomprises the step of operating the pumping device using a wirelessremote control.

According to another embodiment the method further comprises the step ofthe fluid flowing back from the device to the reservoir therebyreleasing the stretching of the stomach wall.

According to another embodiment the step of increasing the distancebetween the first part of the stomach wall and the second part of thestomach wall comprises the step of operating a motor adapted increasethe distance between the first part of the stomach wall and the secondpart of the stomach wall, thereby stretching a portion of the stomachwall.

The step of operating the motor could comprise the step of operating themotor using a wireless remote control.

According to another embodiment the method could further comprises thestep of: sensing a variable using an implantable sensor, interpretingthe sensed variable, using the interpreted variable to control thedevice.

According to another embodiment the step of controlling the device couldcomprise the steps of: operating a pumping device, for moving the fluidfrom a reservoir to the chamber, and the chamber being filled with thefluid increasing the distance between the first part of the stomach walland the second part of the stomach wall and thereby stretching theportion of the stomach wall.

According to another embodiment the method further comprise the step ofthe fluid flowing back from the device to the reservoir therebyreleasing the stretching of the stomach wall.

According to another embodiment the step of sensing a variable comprisesthe step of sensing a variable connected to the food intake of thepatient.

According to another embodiment the method further comprises the stepof: sensing a variable using an implantable sensor, interpreting thesensed variable, using the interpreted variable to control the device.The step of sensing a variable could comprise the step of sensing avariable connected to the food intake of the patient. The step ofincreasing the distance between the first part of the stomach wall andthe second part of the stomach wall could comprise the step of operatinga mechanical device adapted increase the distance between the first partof the stomach wall and the second part of the stomach wall, therebystretching a portion of the stomach wall. The first and second portionsof the device could comprise mechanical members adapted to move forstretching a portion of the stomach wall between the first and secondpart of the stomach wall.

According to another embodiment the method comprises a motor, whereinthe mechanical members is moving for stretching a portion of the stomachwall using the motor.

According to another embodiment the step of stretching a portion of thestomach wall comprises the step of operating at least one mechanicaldevice for stretching a portion of the stomach wall.

According to another embodiment the step of invaginating the mechanicaldevice in the stomach wall comprises invaginating with stomach tostomach sutures.

According to another embodiment the method further comprises the step ofexpanding the mechanical device in the invaginated stomach wall tostretch the stomach wall.

According to another embodiment the invaginated mechanical devicecomprises a motor, expanding the invaginated mechanical device.

The device could further comprise a memory metal or a hydraulicallycontrolled mechanical device, expanding the stomach wall.

Placing

According to another embodiment the step of placing a device comprisesplacing the device in connection with the stomach wall, on the outsidethereof, or in the stomach fundus wall, or in connection with thestomach wall, on the inside thereof.

According to another embodiment the step of placing a device inconnection with the stomach wall, on the inside thereof could comprisethe steps of: cutting a hole in the stomach wall, and inserting thedevice through the hole in the stomach wall.

According to another embodiment the step of placing a device comprisesplacing the device in the stomach fundus wall of the patient.

Fixation

According to another embodiment the step of fixating the at least onedevice comprises suturing or stapling the at least one device to thestomach wall, e.g. by means of stomach-to-stomach sutures or staplers.

The step of fixating the at least one device could comprise placing amesh adapted to be fixated to the stomach wall by means of fibrotictissue. The mesh could be additionally supported by sutures or staplersand adapted to promote the growth in of human tissue, such as a net likestructure.

Control Unit

According to another embodiment the method could comprise the step ofplacing a transferring member from the device to a control unit. Thetransferring member could comprise a fluid transferring member, or atransferring member adapted to transfer electrical power.

According to another embodiment the method further comprises the step ofplacing the control unit, which could be placed subcutaneously in thepatient.

According to another embodiment the step of placing the control unitsubcutaneously further comprises the steps of: inserting the controlunit into the hole in the abdomen of the patient, and fixating thecontrol unit.

An additional method is also provided, the method comprising the stepsof: creating a hole in the stomach wall; introducing the stretchingdevice into the abdomen; moving the device through the hole and placingit on the inside of the stomach wall; creating a pouch of a portion ofthe stomach wall outside the stomach cavity, with the device placedagainst the inside of the stomach wall; invaginating the device in thepouch to the stomach wall; and sealing the hole, preferably with suturesor staples.

According to another embodiment the method according to any of theembodiments could comprise the steps of: creating a hole in the stomachwall; moving the device through the hole and placing it on the inside ofthe stomach wall; introducing the device by means of the instrument intothe pouch; and sealing the hole, preferably with sutures or staple's.

According to another embodiment the method further comprises providing adevice for regulating the stretching device from the outside of thepatient's body; and operating the device to regulate the device.

According to another embodiment the device comprises an implantablecontrol unit and the method further comprises the steps of; providing animplanted control unit for regulating the stretching device from theinside of the patient's body; and operating the device to regulate thedevice.

The method could further comprise the steps of subcutaneously placing aninjection port and connecting a tube connected to the device to theinjection port.

According to another embodiment the method further comprises the step ofproviding a tube connected to the stretching device through the hole andfurther up to the abdominal wall or passing through the abdominal wall.

According to another embodiment the method further comprises the stepsof: receiving a tube from the abdominal cavity of the patient, connectedto the stretching device, and filling the device with fluid injectedthrough the tube.

According to another embodiment the method could further comprise thesteps of: subcutaneously placing an injection port, and connecting thetube to the injection port.

The method could further comprise the additional step of postoperativelyand non-invasively regulating the device to stretch a part of thestomach wall to affect the appetite of the patient.

According to another embodiment the method comprises the additional stepof filling the device with a fluid.

According to another embodiment the method could comprise the additionalstep of placing an internal control, unit within the patient's body.

According to one embodiment the method further comprises the additionalstep of connecting the internal control unit to the device, which couldbe done hydraulically or using electrical wires.

An additional surgical or laparoscopic method of treating obesity of apatient using a device adapted to stretch a portion of the stomach wallof the patient is provided. The method comprising the steps of:inserting a needle or tube like instrument into the abdomen of thepatients body, using the needle or tube like instrument to fill thepatient's body with gas, placing at least two laparoscopic trocars inthe patient's body, inserting a camera through one of the laparoscopictrocars in the patient's body, inserting at least one dissecting toolthrough one of the at least two laparoscopic trocars, dissecting an areaof the stomach, introducing a device into the abdominal cavity,invaginating the device on the outside of the stomach wall with stomachto stomach sutures or staplers and postoperatively stretching theinvaginated stomach wall portion by operating the device.

According to another embodiment the method comprises the additional stepof; introducing a second or more device into the abdominal cavity,invaginating the second or more device on the outside of the stomachwall with stomach to stomach sutures or staplers and postoperativelystretching the invaginated stomach wall portion by operating the secondor more device.

According to another embodiment the method comprises the additional stepof; postoperatively stretching the invaginated stomach wall portion atthe first or second or more parts of the device independent from eachother.

An additional surgical or laparoscopic method of treating obesity of apatient using a device adapted to stretch a portion of the stomach wallof the patient is provided. The method comprises the steps of: insertinga needle or tube like instrument into the abdomen of the patients body,using the needle or tube like instrument to fill the patient's body withgas, placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars in thepatient's body, inserting at least one dissecting tool through one ofthe at least two laparoscopic trocars, dissecting an area of thestomach, introducing a device into the abdominal cavity, invaginating afirst part of the stretching device placed on the outside of the stomachwall with stomach to stomach sutures or staplers and invaginating asecond part of the stretching device, separate from the first part,placed on the outside of the stomach wall with stomach to stomachsutures or staplers and postoperatively stretching the stomach wallportion between the first and second part by operating the device.

According to another embodiment the method comprises the additional stepof; introducing a second or more device into the abdominal cavity,invaginating a first part of the stretching second or more device placedon the outside of the stomach wall with stomach to stomach sutures orstaplers, invaginating a second part of the second or more stretchingdevice, separate from the first part, placed on the outside of thestomach wall with stomach to stomach sutures or staplers, andpostoperatively stretching the stomach wall portion between the firstand second part by operating the second or more device.

According to another embodiment the method comprises the additionalsteps of; invaginating a third or more part of the stretching deviceplaced on the outside of the stomach wall, separate from the first orsecond part, with stomach to stomach sutures or staplers andpostoperatively stretching the stomach wall portion between anycombination of the first and second part and third or more parts, byoperating the device.

A surgical method of treating obesity of a patient using a deviceadapted to stretch a portion of the stomach wall of the patient, themethod comprising the steps of: cutting the skin of a human patient,dissecting an area of the stomach, introducing a device into theabdominal cavity, invaginating the device on the outside of the stomachwall with stomach to stomach sutures or staplers, and postoperativelystretching the invaginated stomach wall portion by operating the device.

The method could further comprise the additional step of; introducing asecond or more device into the abdominal cavity, invaginating the secondor more device on the outside of the stomach wall with stomach tostomach sutures or staplers, and postoperatively stretching theinvaginated stomach wall portion by operating the second or more device.

According to another embodiment the method comprises the additionalsteps of; postoperatively stretching the invaginated stomach wallportion at the first or second or more parts of the device independentfrom each other.

An, additional surgical method of treating obesity of a patient using adevice adapted to stretch a portion, of the stomach wall of the patientis provided. The method comprising the steps of: cutting the skin of ahuman patient, dissecting an area of the stomach, introducing a deviceinto the abdominal cavity, invaginating a first part of the stretchingdevice placed on the outside of the stomach wall with stomach to stomachsutures or staplers, invaginating a second part of the stretchingdevice, separate from the first part, placed on the outside of thestomach wall with stomach to stomach sutures or staplers, andpostoperatively stretching the stomach wall portion between the firstand second part by operating the device.

According to another embodiment the method comprises the additional stepof; introducing a second or more device into the abdominal cavity,invaginating a first part of the stretching second or more device placedon the outside of the stomach wall with stomach to stomach sutures orstaplers, invaginating a second part of the second or more stretchingdevice, separate from the first part, placed on the outside of thestomach wall with stomach to stomach sutures or staplers, andpostoperatively stretching the stomach wall portion between the firstand second part by operating the second or more device.

According to another embodiment the method further comprises the stepsof invaginating a third or more part of the stretching device placed onthe outside of the stomach wall, separate from the first or second part,with stomach to stomach sutures or staplers, and postoperativelystretching the stomach wall portion between any combination of the firstand second part and third or more parts, by operating the device.

According to another embodiment the method comprises the additionalsteps of postoperatively and noninvasively regulating the device tostretch a part of the stomach wall to affect the appetite of thepatient.

The method according to any embodiment could further comprise the stepof filling the device with a fluid.

According to another embodiment the method comprises the additional stepof placing an internal control unit within the patient's body, andconnecting the internal control unit to the device, which could be donehydraulically or using electrical wires.

Instrument

An instrument for placing a device adapted to stretch a part of thestomach wall of a patient in connection with the stomach wall is furtherprovided. The instrument comprises: a holding member adapted toreleaseably hold the device, and a fixating member, adapted to assist inthe fixation of the device to the stomach wall, on the outside thereof.

The instrument could further comprise an optical member for viewing inthe area of the stomach.

The instrument could comprise a fixation member adapted to suturing thedevice to the stomach wall, on the outside thereof.

According to another embodiment the fixation member is adapted forstapling the device to the stomach wall, on the outside thereof, and inother embodiments the fixation member is adapted for invaginating atleast a part of the device in the stomach wall with stomach-to-stomachsutures, on the outside thereof.

According to another embodiment the fixation member could be adapted forinvaginating at least a part of the device in the stomach wall withstomach-to-stomach staplers, on the outside thereof.

An instrument for placing a device adapted to stretch a part of thestomach wall of a patient in connection with the stomach wall is furtherprovided. The instrument comprises: a holding member adapted toreleaseably hold the device, an insertion member adapted to insert thedevice through the stomach wall, and a fixating member, adapted toassist in the fixation of the device to the stomach wall, on the insidethereof.

The instrument could further comprise a cutting member for cutting ahole in the stomach wall, an optical member for viewing in the area ofthe stomach. The fixation member could be adapted for suturing thedevice to the stomach wall, on the inside thereof; or for stapling thedevice to the stomach wall, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach sutures, on the inside thereof, or for invaginatingat least a part of the device in the stomach wall withstomach-to-stomach staplers, on the inside thereof.

The instrument could further comprise a special holding device, whichcould comprise a special holding device adapted to hold the stomachusing vacuum or using mechanical holding members.

These objects and others are obtained by device described in theappended claims. Thus, by providing a device that comprises at least oneoperable stretching device implantable in an obese patient and adaptedto stretch a portion of the patient's stomach wall, and an operationdevice for operating the stretching device when implanted to stretch thestomach wall portion such that satiety is created, a device for treatingobesity is obtained. The present invention is based on the realizationthat by creating a stretching effect of the stomach wall a feeling ofsatiety is created. As a result, there is no need for providing areduced permanent stoma in the stomach as required by AGB and VBG. Thus,the complications associated with such a reduced stoma are eliminated bythe new device of the present invention, which is a simpler, safer andlong term working device.

The stretching device may be kept in contact with the stomach wall bystomach-to-stomach sutures or staplers, in a position in which thestretching device is capable of stretching the stomach wall.Specifically, the stretching device may be invaginated by the stomachwall by means of stomach-to-stomach sutures or staplers.

The stretching device may be adapted to be placed in the stomach cavity.To this end, the stretching device may be adapted to be inserted intothe stomach cavity via a gastroscope or intraluminar instrument, and beadapted to be attached to the stomach wall by surgery. Alternatively,the stretching device may be adapted to be placed on the outside of thestomach.

In an embodiment of the invention, the stretching device comprises afirst engaging member adapted to engage a first part of the stomach walland a second engaging member adapted to engage a second part of thestomach wall close to but spaced from the first stomach part. Theoperation device is adapted to operate the first and second engagingmember to move away from each other to stretch the stomach wall portionbetween the first and second parts of the stomach such that satiety iscreated. At least one of the first and second engaging members may beadapted to at least in part be invaginated by the stomach wall bystomach-to-stomach sutures or staplers holding the engaging member inplace. In addition, at least one of the first and second engagingmembers may be adapted to be kept in place by sutures or staplersbetween the engaging member and the stomach wall. Suitably, at least oneof the first and second engaging members comprises a tissue growthpromoting structure, preferably a net like structure, adapted to be incontact with the stomach wall to secure long term attachment of thestretching device to the stomach wall.

In another embodiment of the invention, the stretching device comprisesat least one expandable body adapted to be invaginated by a portion ofthe patient's stomach wall, and the operation device comprises a fluidreservoir, which is in fluid communication with a chamber of the body.The operation device is non-invasively operable to distribute fluid fromthe fluid reservoir to the chamber of the body to expand the body suchthat the stomach wall portion is stretched, when the body isinvaginated. The fluid reservoir may be operated by manually pressingit. The operation device may comprise a reverse servo, wherein a smallvolume of fluid in the fluid reservoir is compressed with a higher forceand the chamber of the body creates a movement of a larger total volumewith less force per unit of volume. The fluid reservoir may be placedsubcutaneously or in the abdomen, and may be regulated by moving a wallof the reservoir, for example by a motor. Alternatively, a pump may beprovided for pumping fluid or air from the reservoir to the body'schamber.

The term “reversed servo means” encompasses the definition of a devicethat is controlled with a higher force and a small stroke i.e. forexample movement of a small amount of fluid with a high force controls alarger amount of fluid moving by means of very smaller force, but mayalternatively or additionally encompass the definition of a mechanismthat transfers a strong force acting on a moving element having a shortstroke into a small force acting on another moving element having a longstroke. The reversed servo means is preferably used when manual controlof the device through intact skin is possible.

In another embodiment of the invention, the device comprises a largechamber in contact with one or more smaller chambers. The chambers areadapted to communicate with fluid or air being distributed between thechambers. A reversed servo for distributing fluid between the chambersmay be provided, wherein a small volume of fluid in the large chamber iscompressed with a higher force and the smaller chamber creates amovement of a larger total volume with less force per unit of volume.The large chamber may be adapted to be invaginated in the patient'sfundus stomach wall to also treat reflux disease by restricting movementof the cardiac notch towards the diaphragm muscle of the patient,whereas the small chambers function as stretching devices to treatobesity. The large chamber may distribute fluid or air to the smallchambers to cause them to expand and stretch the stomach fundus wall.

In another embodiment of the invention, the stretching device comprisesa mechanical stretching device, wherein a motor for mechanicallyregulating the stretching device may be provided. The mechanicallyregulated stretching device may be adapted to engage a first part of thestomach wall and a second part of the stomach, wherein the mechanicallyregulated stretching device comprises a joint mechanism adapted to bemoved by the operation device. Alternatively, the stretching device maycomprise a first engaging member adapted to engage a first part of thestomach wall and a second engaging member adapted to engage a secondpart of the stomach wall close to but spaced from the first stomachpart, wherein the mechanical stretching device regulates the distancebetween the first and second parts of the stomach wall.

As an alternative, the hydraulic means described above may be used forregulating such a mechanical stretching device by the hydraulicdistribution of fluid or air.

The stretching device may be non-invasively adjustable postoperatively.

The operation device for operating the stretching device may in itssimplest form comprise a subcutaneous switch adapted to benon-invasively operated by manually pressing the switch for theoperation of the stretching device.

At least two operable stretching devices adapted to stretch at least twodifferent portions of the stomach wall may be provided, wherein thedevice is adapted to be postoperatively and non-invasively regulated.Specifically, the device may be regulated from time to time such that ata first time one of the stretching devices stretches one of the portionsof the stomach wall and at a second time the other of the stretchingdevices stretches the other portion of the stomach wall.

In another embodiment of the invention, the stretching device comprisesa body adapted to till out a volume defined by wall portions of thestomach. The body suitably has rounded contours without too sharp edgesthat would be damaging to the patient's stomach wall. Where the body isto be invaginated it may have varying circumference to better be kept inplace invaginated by stomach wall portions of the patient. The body maybe shaped like an egg or like a kidney.

Generally, any kind of mechanical construction may be used. Anymechanical construction driven mechanically or hydraulically or anypneumatic construction may be used. Any motor or any pump or movingmaterial changing form when powered may be used to achieve the simplegoal of stretching a part of the stomach wall by moving at least twopart s of the stomach wall away from each other.

Any kind of hydraulic operation may be used. It will be appreciated thatinstead of hydraulic operation, pneumatic operation can be used, whereinair instead of hydraulic fluid is moved between a reservoir and achamber formed by the stretching device. Preferably the reservoir has alocking position to keep it in the desired position if it is handled bythe patient. To compress the reservoir it preferably stays compressedand releases after pressing again.

Any kind of hydraulic solution may be used for the stretching device.The hydraulic solution may be driven by both mechanically and poweredwith any motor or pump as well as manual.

Of course just expanding an invaginated part of the stomach alsostretches away the stomach wall which also may be achieved bothmechanically, hydraulically, pneumatically and both being powered with amotor or pump or by manual force.

According to one embodiment, a device for treating obesity of a patientis provided, the device comprises at least one operable stretchingdevice implantable in the patient and adapted to stretch a portion ofthe patient's stomach wall. The device further comprises an implantablecontrol unit for automatically controlling the operable stretchingdevice, when the control unit and stretching device are implanted, tostretch the stomach wall portion in connection with the patient eatingsuch that satiety is created.

According to another embodiment the device further comprises at leasttwo stretching devices, a first stretching device and a secondstretching device, or three or more stretching devices. According to yetanother embodiment the device further comprises an operation device foroperating the stretching device, wherein the control unit controls theoperation device to stretch the stomach wall portion, when the controlunit and stretching device are implanted.

According to yet another embodiment the device further comprising asensing device including a sensor for sensing a physical parameter ofthe patient or a functional parameter of the stretching device, whereinthe sensing device sends information relating to the parameter to thecontrol unit, and the control unit controls the stretching device basedon the information. The device could be adapted to control thestretching device to intermittently stretch the stomach wall, when thecontrol unit and stretching device are implanted.

According to one embodiment the implantable control unit is adapted tocontrol the amount of stretching performed by the stretching device onthe stomach wall, according to one embodiment by vary over time, theamount of stretching of the stomach wall and/or to stretch the stomachduring a predetermined time period.

According to one embodiment the implantable control unit is adapted tocontrol the stretching device based on the patient's food intake, theimplantable control unit could be programmable to include any of apredetermined time period during which the stretching device iscontrolled to stretch the stomach wall, and the magnitude of stretchingapplied on the stomach wall. The operation device could be a mechanicaloperation device, hydraulic operation device, a hydraulically operatedmechanical operation device or a mechanically operated hydraulicoperation device.

According to one embodiment the sensor of the sensing device senses thepatient's food intake directly or indirectly, and the implantablecontrol unit controls the operation device to stretch the stomach wallin response to signals from the sensor.

According to yet another embodiment the implantable control unit isadapted to control the operation device to stretch the stomach wallusing more than one stretching device. This could be done by theimplantable control unit being adapted to control the first stretchingdevice, during a first time period, to stretch a first portion of thestomach wall, and the second stretching device, during a second timeperiod, to stretch a second portion of the stomach wall different fromsaid first portion of the stomach, to allow longer relaxation of thestomach wall in between stretching periods.

According to one embodiment the sensor of the sensing device is adaptedto sense a parameter related to the patients food intake such asesophagus movement, esophagus bending, esophagus motility, esophagusstretching, esophagus pressure, food passing esophagus, food in thestomach, neural activity, vagus activity, muscle activity, hormonalactivity, stomach motility, stomach stretching, stomach pressure,stomach bending, stomach filling, and/or acidity in the stomach. Thesensing device could also be adapted to senses motility, stretching,bending, pressure, movement, a hormone, neural activity, PH-level,acidity, volume, capacitance, resistance, volt, ampere, light absorptionor visualization, ultrasound reflection or absorption, bending metal,bimetal and PH.

According to one embodiment the device further comprises an implantablereservoir, wherein the operation device is hydraulically controlled bythe reservoir. The stretching device could be adapted to be controlledfrom outside the patient's body using a patient control which accordingto one embodiment could be adapted to override the control of theimplantable control unit. The implantable control unit could be adaptedto be controlled from outside the patient's body by the patient.

According to one embodiment the device further comprises an externalcontrol unit for controlling the implantable control unit from outsidethe patient's body e.g. by means of an implantable switch operable bythe patient.

According to one embodiment the device comprises a wireless remotecontrol for controlling and/or programming the implantable control unitfrom outside the patient's body. The control unit could comprise a forcecontroller, and the mechanical operation device could be controlled bythe force controller.

According to one embodiment the implantable control unit comprises apressure controller, and the hydraulic operation device is controlled bythe pressure controller.

Stretching Device

The stretching device of the device according to any of the embodimentscould comprise a first and a second engaging part, the first part couldbe adapted to be engaged to a first area of the stomach wall, and thesecond part could be adapted to be engaged to a second area of thestomach wall. The stretching device is thereby adapted to stretch aportion of the stomach wall between the first area and the second area.The stretching device could comprise a motor, such as an implantableelectrical motor, which in turn could operate at least one joint to movethe joint to stretch the stomach wall portion.

According to another embodiment the device could comprise a chamberhaving a variable volume; the chamber could be adapted to receive afluid. The device could further comprise a reservoir adapted to hold afluid and to be in fluid connection with the chamber. The stretchingdevice could further comprise a pumping device, which could be adaptedto move the fluid from the reservoir to the chamber, and therebystretching the portion of the stomach wall. According to anotherembodiment the device further comprises a second fluid connectionadapted to enable the fluid to flow back from the chamber to thereservoir during a predetermined time period.

Hydraulic

According to one embodiment the stretching device comprises a chamberadapted to have a variable volume. The chamber could comprise at leastone moveable wall portion, which could be an elastic wall portion. Thechamber could have an essentially round shape and could be adapted toreceive a fluid.

According to another embodiment the stretching device further comprisesa reservoir adapted to hold a fluid and to be in fluid connection withthe chamber, the stretching device could further comprise a pumpingdevice, which could be adapted to move the fluid from the reservoir tothe chamber via a first fluid connection interconnecting the reservoirand chamber, thereby stretching the portion of the stomach wall. It isalso conceivable that the stretching device further comprises a secondfluid connection interconnecting the chamber and reservoir and adaptedto enable the fluid to flow back from the chamber to the reservoirduring a predetermined time period.

The reservoir according to any of the embodiment could be adapted to beplaced subcutaneously or in the abdomen and the reservoir could becontrolled by moving a wall of the reservoir which could be done using amotor adapted therefore. The chamber could also comprise an electricalmotor adapted to expand the volume of the chamber.

The device could further comprise a reverse servo, wherein a smallvolume in the reservoir is compressed with a higher force and thechamber creates a movement of a larger total area with less force perarea unit.

Sensor

The sensor implanted in the patient according to any of the embodimentscould be a functional parameter sensor sensing a functional parameter ofthe device, such as the transfer of energy for charging an internalenergy source. In other embodiments the sensor is a physical parametersensor sensing a physical parameter of the patient, such as the foodintake of the patient. The sensor according to any of the embodimentscould be at least one of body temperature sensors, pressure sensors,blood pressure sensors, blood flow sensors, heartbeat sensors, breathingsensors, electrical conductivity sensors, pH sensor, light sensitivesensors, gas detection sensors and sensors sensing mechanical strain,such as a sensor adapted to sense any of contraction and relaxation ofthe Cardia.

According to one embodiment the device further comprises a feedbackdevice for sending information from inside the patient's body to theoutside thereof to give feedback information related to the functionalparameter.

Control Unit

According to one embodiment the device is controlled by a control unitadapted to control the stretching device. The control unit could beadapted to control the stretching device, or two or more stretchingdevices, in response to signals from the sensor.

According to one embodiment the control unit controls the stretchingdevices from time to time such that one of the stretching devices at afirst time stretches a first portion of the stomach wall and another ofthe stretching devices at a second time stretches a second portion ofthe stomach wall. The control unit could be adapted to be controllablefrom outside of the patient's body, e.g. through a wireless remotecontrol, which in turn could comprises at least one external signaltransmitter, which could be adapted to transmit a wireless controlsignal comprising a frequency, amplitude, or phase modulated signal or acombination thereof. According to one embodiment the at least onetransmitter is adapted to transmit a wireless control signal comprisinga analogue or a digital signal, or a combination of an analogue anddigital control signal, or a wireless control signal comprising anelectric or magnetic field, or a combined electric and magnetic field.

The control unit according to any of the embodiments could be adapted tobe implanted subcutaneously in the human patient, and could be adaptedto control a hydraulic system.

The device could further comprise a transferring member for powering thecontrol unit, the transferring member could comprise a fluidtransferring member and/or an electrical lead.

According to another embodiment the device further comprises an externaldata communicator and an implantable internal data communicatorcommunicating with the external data communicator. The internalcommunicator could be adapted to feed data related to the device fortreating obesity or the patient back to the external data communicatoror the external data communicator feeds data to the internal datacommunicator.

Energizing

For energizing the device the device could further comprise a wirelessenergy transmitter transmitting energy by at least one wireless energysignal, such as a wave signal, e.g. a sound wave signals, ultrasoundwave signals, electromagnetic wave signals, infrared light signals,visible light signals, ultra violet light signals, laser light signals,micro wave signals, radio wave signals, x-ray radiation signals and agamma radiation signals. The wireless energy signal could furthercomprise an electric or magnetic field, or a combined electric andmagnetic field.

According to yet another embodiment the device comprises an energysource adapted to power the device, which could comprise an internalenergy source which in turn could be adapted to receive energy from anexternal energy source transmitting energy in a wireless mode. Theinternal energy source could further comprise an accumulator, at leastone voltage level guard and/or at least one constant current guard.

The device could further comprise an energy-transforming device adaptedto transform energy from a first form into a second form.

Fixation

The device according to any of the embodiments could comprise a fixatingmember, which could be adapted to fixate the stretching device to thestomach wall of the patient. The fixating member could be adapted to bein contact with sutures or staplers for fixating the stretching deviceto the stomach wall of the patient. The fixating member could comprise anet like structure, which could be adapted to promote growth in of humantissue for long term fixation to the stomach wall.

System

The present invention also provides an obesity treatment systemcomprising a device for treating obesity as described above. The systemmay comprise a subcutaneous electric switch adapted to manually andnon-invasively control a function of the device for treating obesity.

The system may comprise a hydraulic device having a hydraulic reservoir,wherein the device for treating obesity is adapted to non-invasively beregulated by manually pressing the hydraulic reservoir.

The system may comprise a wireless remote control for controlling afunction of the device. The wireless remote control comprises at leastone external signal transmitter and an internal signal receiver may beprovided to be implanted in the patient. The wireless remote control isadapted to transmit at least one wireless control signal for controllingthe device. The wireless control signal may comprise a frequency,amplitude, or phase modulated signal or a combination thereof, and ananalogue or a digital signal, or a combination of an analogue anddigital signal. Alternatively, the wireless control signal comprises anelectric or magnetic field, or a combined electric and magnetic field.The remote control may transmit a carrier signal for carrying thewireless control signal. The carrier signal may comprise digital,analogue or a combination of digital and analog signals. The remotecontrol may transmit an electromagnetic carrier wave signal for carryingthe digital or analog control signal.

The system may comprise a wireless energy transmitter for non-invasivelyenergizing the device with wireless energy. The energy transmittertransmits energy by at least one wireless energy signal. The wirelessenergy signal may comprise a wave signal selected from the following: asound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal and a gamma radiation signal.Alternatively, the wireless energy signal comprises an electric ormagnetic field, or a combined electric and magnetic field. The wirelessenergy transmitter may transmit a carrier signal for carrying thewireless energy signal. The carrier signal may comprise digital,analogue or a combination of digital and analog signals.

The system may comprise an energy-transforming device for transformingthe wireless energy from a first form into a second form energy. Theenergy-transforming device may directly during energy transfer operatethe device with the second form energy. The second form energy maycomprise a direct current or pulsating direct current, or a combinationof a direct current and pulsating direct current. The second form energymay comprise an alternating current or a combination of a direct andalternating current. An accumulator may be provided, wherein the secondform energy is used at least partly to charge the accumulator. Theenergy of the first or second form may comprise magnetic energy, kineticenergy, sound energy, chemical energy, radiant energy, electromagneticenergy, photo energy, nuclear energy or thermal energy. One of theenergy of the first form and the energy of the second form may benon-magnetic, non-kinetic, non-chemical, non-sonic, non-nuclear ornon-thermal.

The system may comprise an energy source adapted to power the device.The energy source may comprise an internal energy source adapted toreceive energy from an external energy source transmitting energy in awireless mode. The internal energy source is charged by the energy inthe wireless mode.

The system may comprise a feedback device for sending information frominside the patient's body to the outside thereof to give feedbackinformation related to a functional parameter.

The system may comprise a sensor sensing a parameter, such as afunctional parameter of the system, which is correlated to the transferof energy for charging an internal energy source. An internal controlunit may be provided for controlling the operation device of the devicein response to the sensor sensing a functional parameter. Alternatively,sensor senses a physical parameter of the patient. The physicalparameter may be one of body temperature, blood pressure, blood flow,heartbeats and breathing. The physical parameter sensor may be apressure or motility sensor, or a sensor sensing measure, bending,stretching or food intake. The internal control unit may control theoperation device in response to the sensor sensing the physicalparameter. An internal control unit may be provided for receivinginformation from the sensor.

The operation device of the device may comprise a motor or a pump.Specifically, the operation device may comprise an electric motor. Theoperation device may be electrically powered, may be a hydraulicoperation device or may be a pneumatic operation device. The transmittedenergy, directly in its wireless form may affect the operation device tocreate kinetic energy to operate the stretching device of the deviceduring energy transfer.

The system may comprise a feedback device for sending information frominside the patient's body to the outside thereof to give feedbackinformation related to a functional parameter.

The system may comprise an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator, wherein the internal communicator is adapted to feed datarelated to the device for treating obesity or the patient back to theexternal data communicator or the external data communicator feeds datato the internal data communicator.

The system may comprise implantable electrical components including atleast one voltage level guard and/or at least one constant currentguard.

Methods

The present invention also provides methods as listed below:

a) A method for surgically treating an obese patient, the methodcomprising the steps of:cutting an opening in the abdominal wall of the patient,dissecting an area around the stomach,placing a device for treating obesity as described above, engaging thestomach wall of the patient, and suturing the stomach wall.

The method may further comprise the additional step of: postoperativelyregulating the stretching device to stretch a part of the stomach wallto affect the appetite of the patient, wherein the step of regulatingthe stretching device is controlled from outside the patient's body.

The method may further comprise the additional steps of: placing anadditional device for treating obesity as described above, engaging thestomach wall of the patient, stretching a first part of the stomach wallby means of the device for treating obesity, and stretching a secondpart of the stomach wall by means of the additional device for treatingobesity.

b) A method for surgically placing a device for treating obesity in apatient via a laparoscopic abdominal approach, the method comprising thesteps of:inserting a needle or a tube like instrument into the abdomen of thepatient's body, using the needle or a tube like instrument to fill thepatient's abdomen with gas thereby expanding the patient's abdominalcavity.placing at least two laparoscopic trocars in the patient's body,inserting a camera through one of the laparoscopic trocars into thepatient's abdomen,inserting at least one dissecting tool through one of the at least twolaparoscopic trocars and dissecting an intended placement area of thepatient, andplacing a device for treating obesity as described above, engaging thestomach wall.c) A method of using the system for heating obesity as described above,comprising the step of regulating the stretching device postoperativelyto stretch a portion of the stomach wall to affect the appetite of thepatient, wherein the step of regulating the stretching device isperformed non-invasively. The stretching device comprises a mechanicalor hydraulic stretching device. The hydraulic stretching device maycomprise a reservoir, for moving gel or gas or fluid to or from thestretching device. The reservoir may be placed subcutaneously for beingreached by the patients hand for moving fluid manually to or from thestretching device. The stretching device may be powered by an internalenergy source for stretching or releasing the stretching device, whereinby means of a control device controlling the power from an internalcontrol unit or from the outside the patient's body. A wireless energytransmitter for wireless transfer of energy powers the operation deviceto get the stretching device to directly during energy transfer causethe stretching device to stretch the stomach wall. A wireless energytransmitter for wireless transfer of energy charges the internal energysource. A reversed servo may be provided, wherein moving, in a closedhydraulic system, a small amount of fluid, a larger movement of fluid isachieved in a second larger closed hydraulic system, wherein the smallamount of fluid is moved with by a higher force per area unit than thelarge volume. An invaginated stretching device in the fundus stomachwall of the patient is adapted to be adjustable, wherein the stretchingdevice placed invaginated in the stomach fundus wall is adapted to beadjusted and stretching the stomach fundus wall thereby creatingsatiety.

The method may further comprise sending feedback information from insidethe body to the outside thereof to give feedback related to thefunctional parameters of the device. Alternatively, the method mayfurther comprise sending feedback information from inside the body tothe outside thereof to give feedback related to the physical parametersof the patient. The functional parameter of the device may be correlatedto the transfer of energy for charging the internal energy source. Thedevice is programmable from outside the patient's body.

The method may further comprise the steps of:

sensing a physical parameter of the patient or a functional parameter ofthe device, andsending sensing information to a control unit adapted for regulating thestretching device.

The method may further comprise the steps of:

sensing a physical parameter of the patient or a functional parameter ofthe device, andsending sensing information to a control unit adapted for regulating thecharging of the internal energy source.

The method may further comprise subcutaneously placing a reversed servohaving a small control reservoir and moving a small volume from thecontrol reservoir with a higher force per area unit, creating a largermovement of the stretching device with less force per area unit.

The method may further comprise performing the non-invasive regulationby manually pressing a subcutaneous switch.

The method may further comprise performing the non-invasive regulationby a wireless remote control.

The method may further comprise performing the non-invasive regulationby a wireless energy transmitter.

The method may further comprise powering the device for treating obesityby an internal energy source.

The method may further comprise powering the device for treating obesityby an external energy source transmitting wireless energy, wherein theenergy source comprises an external energy source transmitting wirelessenergy.

The method may further comprise transmitting wireless energy from anexternal energy source to charge a rechargeable internal energy source.

d) A method of using a device as described above, wherein the stretchingdevice comprises a main body including a large chamber in contact withone or more smaller reservoirs/chambers adapted to stretch the stomachwall, wherein the chambers are adapted to communicate with fluid or airbeing moved between the chambers.e) A method of using a device as described above, wherein the largechamber are adapted to, with its main volume to be the stretchingdevice's most important volume and wherein, the small chambers are asthe stretching devices stretching the stomach wan to treat obesity,wherein the main chamber is communicating with fluid or gel to the smallchambers causing the stretching effect in the stomach fundus wallthereby treating obesity.f) A method of using a device as described above, comprising treatingreflux disease by invaginating the large chamber with its main volume inthe fundus stomach wall thereby restricting movement of the stomachnotch towards the diaphragm muscle of the patient, and stretching thestomach fundus wall using the small chambers, communicating with fluidor air from the large chamber to the small chambers causing a stretchingeffect in the stomach fundus wall thereby treating obesity.

A stretching device, adapted to post-operatively be adjustable andcomprising at least one expandable section, wherein the stretchingdevice is adapted to be adjustable between a first collapsed state and asecond expanded state. In the first collapsed state the expandablesection is collapsed, and in the second expanded state, the expandablesection is expanded. The outer surface of said expandable section doesat least partly comprise a surface structure having elevated areasalternating with lowered areas. The expandable section is adapted tohave, in at least one of said first collapsed and second expanded statesa first distance between adjacent elevated areas sufficiently extendedto prevent growth of fibrotic tissue from directly interconnectingadjacent elevated areas to an extent that compromises the adjustabilitybetween a first collapsed and a second expanded state of said stretchingdevice. The expandable section further comprising connecting areasbetween adjacent elevated and lowered areas, further adapted to have, inat least one of said first collapsed and second expanded states, asecond distance between adjacent connecting areas sufficiently extendedto prevent growth of fibrotic tissue from directly interconnectingadjacent connecting areas to an extent that compromises theadjustability between a first collapsed and a second expanded state ofsaid stretching device.

According to one embodiment the expandable section is hollow orcomprises a hollow body.

According to another embodiment the stretching device is substantiallycompletely hollow or comprises a hollow body extending alongsubstantially the complete length and/or complete volume of saidstretching device.

Fibrotic tissue can often have an extension or thickness of about 0.5 mmto about 1.5 mm and hence the distances between relevant surfaces of theelements of the surface structure are suitably greater than about 3 mm,hence greater than about 2×1.5 mm. But depending on the circumstancesalso distances greater than about 1.0 mm to about 3 mm may besufficient. In cases where the fibrotic tissue can be expected to havean extension or thickness greater than about 1.5 mm the distancesbetween relevant surfaces of the elements of the surface structure areadapted in a suitable manner.

The surface structure may comprise elevated and lowered areas and it maybe suitable that also a distance between the different planes of theelevated and lowered areas is bigger than a certain threshold tofacilitate the collapsible and/or expandable functionality of thestretching device. If said distance is too small, the collapsible and/orexpandable functionality of the stretching device may be limited. Asuitable interval for said distance is around 0.5 to 10 mm, moresuitable around 2-8 mm and most suitable around 3-7 mm The surfacestructure may comprise different geometrical elements or shapes and anycombination of such elements or shapes as long as the above mentionedconditions for the distances can be met. The surface structure may e.g.comprise ridges and grooves of different shapes. The ridges and groovesmay each have a cross-section that is e.g. wedge-shaped, polygonal,square-formed, pyramidal-shaped, truncated pyramidal-shaped or. Furthermay the ridges and grooves have cross-sections of different shapes. Thesurface structure may as well in general comprise a bellows-shapedstructure or a surface structure where geometrical objects of the sameor different kind(s) are placed on a surface. The geometrical objectsmay be practically randomly placed on the surface or according to somescheme.

One type of stretching devices where this type of surface structure maybe suitable, is stretching devices where the stretching device shouldhave the ability to change shape and/or size substantially. Hence, thisis a case where the presence of fibrotic tissue substantially couldhinder or impede the function of the stretching device. But the surfacestructure may be used by any stretching device where the characteristicsof the surface structure would be advantageous for the stretchingdevice.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIG. 1 shows a stretching device implanted in the stomach fundus wall ofa patient, on the inside thereof.

FIG. 2a shows a stretching device implanted in the stomach fundus wallof a patient, on the outside thereof.

FIG. 2b shows a stretching device implanted in the stomach fundus wallof a patient, on the outside thereof in a second state.

FIG. 3a shows an embodiment where the stretching device comprises twostretching devices, according to a first embodiment.

FIG. 3b shows an embodiment where the stretching device comprises twostretching devices, according to second embodiment.

FIGS. 4a-i shows the stretching device according to differentembodiments.

FIG. 5a is a sectional view of a surface structure 700 of the stretchingdevice 10,

FIG. 56 is a sectional view similar to that of FIG. 5a but with aslightly different surface structure 700,

FIGS. 5c-e are drawings showing sections of examples of the surfacestructure 700 described herein,

FIG. 5f schematically shows an embodiment of a stretching device 10having a surface structure 700,

FIGS. 5g and 5h show examples of different cross sections for aprosthesis,

FIGS. 5i-5k are drawings showing examples of different surfacestructures.

FIGS. 6a-c shows the stretching device invaginated in the stomach wall.

FIG. 7 shows an embodiment wherein the stretching device is a mechanicalstretching device, according to a first embodiment.

FIG. 8a-b show an embodiment wherein the stretching device is amechanical stretching device, according to a second embodiment.

FIG. 9a shows an embodiment wherein the stretching device is amechanical stretching device, according to a third embodiment.

FIG. 9b shows a mesh adapted to assist in the fixation of the stretchingdevice.

FIG. 9c shows an embodiment wherein the stretching device is amechanical stretching device, according to a fourth embodiment.

FIG. 10a shows an embodiment wherein the stretching device is amechanical stretching device, according to a fifth embodiment.

FIG. 10h shows an embodiment wherein the stretching device is amechanical stretching device, according to a fifth embodiment, ingreater detail, in a first state.

FIG. 10c shows an embodiment wherein the stretching device is amechanical stretching device, according to a fifth embodiment, ingreater detail, in a second state.

FIG. 11a shows an embodiment where the stretching device is combinedwith a device for treating reflux decease, according to a firstembodiment.

FIG. 11b shows an embodiment where the stretching device is combinedwith a device for treating reflux decease, according to a secondembodiment.

FIG. 12a shows an embodiment where the stretching device is combinedwith a volume filling device.

FIG. 12b shows yet another embodiment of the stretching device, in amanual version.

FIG. 12c shows yet another embodiment of the stretching device, in anautomatic version.

FIGS. 13-33, 34 a-c, 35 and 36 a-c show schematic figures describingdifferent functions of the stretching device.

FIG. 37a shows the control unit of a gastroscopic instrument.

FIG. 37b shows the gastroscopic instrument when placed in the stomach.

FIG. 37c shows the gastroscopic instrument when penetrating the stomachwall.

FIG. 37d shows the gastroscopic instrument when penetrating the stomachwall, in greater detail.

FIG. 37e shows a gastroscopic or laparoscopic instrument according toone embodiment.

FIG. 37f shows a gastroscopic or laparoscopic instrument according toone embodiment, in a second state.

FIG. 37g shows a gastroscopic or laparoscopic instrument according toone embodiment, in a third state.

FIG. 37h shows a gastroscopic or laparoscopic instrument according toone embodiment, in a fourth state.

FIG. 37i shows a gastroscopic or laparoscopic instrument according toone embodiment, in a fifth state.

FIG. 38a-d shows a gastroscopic or laparoscopic instrument in greaterdetail.

FIG. 39a-j shows a gastroscopic or laparoscopic instrument creating acavity or pocket in the stomach wall and inserting a stretching device.

FIG. 40a-f shows a gastroscopic or laparoscopic instrument creating acavity or pocket in the stomach wall and inserting a stretching device.

FIG. 41a,b shows a gastroscopic or laparoscopic instrument inserting aguiding wire.

FIG. 42 shows a flowchart of a gastroscopic method,

FIG. 43 shows a flowchart of a laparoscopic or surgical method.

DETAILED DESCRIPTION

Invaginated in the stomach wall is to be understood as an object beingplaced inside of a cavity made of stomach wall material. Theinvagination enables stomach to stomach sutures or staplers whichenables the object of be enclosed by means of the human tissue healing.

In the following a detailed description of embodiments will be given. Inthe drawing figures, like reference numerals designate identical orcorresponding elements throughout the several figures. It will beappreciated that these figures are for illustration only and are not inany way restricting the scope. Thus, any references to direction, suchas “up” or “down”, are only referring to the directions shown in thefigures. Also, any dimensions etc. shown in the figures are forillustration purposes.

FIG. 1 shows a first embodiment of an obesity treatment device. Thedevice comprises a stretching device 10 implanted in a human patient. InFIG. 1 the stretching device 10 is invaginated in the wall 12 of thepatient's stomach 12 and the body of the stretching device 10 is shapedto rest against the wall 12 of the stomach 12 and further has an outersurface suitable to rest against this wall 12. This means that thestretching device 10 preferably has an essentially round shape to notdamage the stomach wall. However, the stomach wall 12 is strong so manydifferent shapes and forms may be used.

The stretching device 10 can be fixed to the wall 12 a of the stomach 12in a number of different ways. In the embodiment shown in FIG. 1, thestretching device 10 is invaginated in the stomach wall 12 a. Afterin-vagination, a number of stomach-to-stomach sutures or staplers 14 areapplied to keep the in-vagination in the short term. This allows growthof human tissue, keeping the in-vagination in the long term.

By enlarging the size of the stretching device, the stomach wall 12surrounding the stretching device 10 is stretched since thecircumference of the stretching device 10 is increased. By thisstretching, receptors in the stomach wall indicate that the stomach isfull, thereby creating a feeling of satiety to the patient.Correspondingly, when the stretching device 10 is contracted, thereceptors indicate that the stomach is not full, thereby returning thefeeling of hunger.

The expansion and contraction of the stretching device 10 can beperformed under direct control of the patient. Alternatively, theexpansion and contraction can be performed according to a pre-programmedschedule.

Returning to FIG. 1, this figure also shows a fluid operation device,i.e., a hydraulic or pneumatic operation device suited for operating thestretching device, which in the following will be described in detail.

The stretching device 10 forms a fluid chamber, in which fluid isallowed to flow. The stretching device 10 thus forms an expandablechamber that can change the volume it occupies in the stomach wall,thereby forming a hydraulically or pneumatically regulated stretchingdevice 10.

A regulation reservoir 16 for fluids is connected to the stretchingdevice 10 by means of a conduit 18 in the form of a tube. The stretchingdevice 10 is thereby adapted to be regulated, preferably non-invasively,by moving liquid or air from the regulation reservoir 16 to the chamberformed by the stretching device.

The regulation reservoir 16 can be regulated in several ways. In theembodiment shown in FIG. 1, the regulation reservoir 16 is regulated bymanually pressing the regulation reservoir 16. In other words, theregulation reservoir 16 is regulated by moving a wall of the reservoir.It is then preferred that the regulation reservoir 16 is placedsubcutaneously and non-invasive regulation is thereby achieved.

When the regulation reservoir 16 is pressed, the volume thereofdecreases and hydraulic fluid is moved from the reservoir to the chamberformed by the stretching device 10 via the conduit 18, enlarging orexpanding the stretching device 10. For filling and calibrating thefluid level of the device an injection 1001 port is furthermoreprovided. The injection port preferably comprises self sealing membrane,such as a silicone membrane.

It will be appreciated that instead of hydraulic operation, pneumaticoperation can be used, wherein air instead of hydraulic fluid is movedbetween the reservoir 16 and the chamber formed by the stretching device10. Preferable the reservoir has a locking position to keep it in thedesired position. If the patient compresses the reservoir 16 itpreferably stays compressed and releases after pressing again.

Any kind of hydraulic solution may be used for the stretching device.The hydraulic solution may be driven by both mechanically and be poweredwith any motor or pump as well as manually.

FIG. 1 further shows a reversed servo system which comprises aregulation reservoir 16 and a servo reservoir 90. The servo reservoir 90hydraulically controls a stretching device 10 via a conduit 18. Thereverse servo function is described in greater detail in FIGS. 33-36

FIG. 2a shows the device according to another embodiment in which amotor 40 is adapted to move a wall of the regulation reservoir 16. Thepowered regulation reservoir 16 is then preferably placed in the abdomenof the patient. In this embodiment, a wireless external remote controlunit 34 b,c and an external energy transmission device 34 a can beprovided to perform non-invasive regulation of the motor via an energytransforming device 30, which is adapted to supply an energy consumingoperation device, in the present example the motor 40, with energy.

The remote control may comprise a wireless energy transmitter, 34 awhich also can act as a regulation device for non-invasively regulatingthe stretching device. When the regulation is performed by means of aremote control 34 an internal power source 70 for powering theregulating device is provided. The internal energy source 70 can forexample be a chargeable implanted battery or a capacitor or a device forreceiving wireless energy transmitted from outside the body of thepatient. Different ways of regulating the stretching device 10 will bedescribed below with reference to FIGS. 13-29.

The device as shown in FIG. 2a further comprises a sensor 201 sensing aparameter of the patient or the device preferably connected to the foodintake of the patient. The sensor is connected to a control assembly 42by means of a sensor signal transferring member 202. The sensor can beused to regulate said device in a completely automatic way, i.e. thedevice responds to a sensor signal connected to the food intake of thepatient, thereby affecting the control assembly to operate thestretching device 10 to stretch the stomach wall 12 and thereby creatinga feeling of satiety in the patient. The sensor could be adapted tomeasure the food intake of the patient through any of temperature, bloodpressure, blood flow, heartbeats, breathing and pressure and can beplaced in the stomach 12, esophagus 203 or in connection with the cardia204. According to one embodiment said sensor is a strain gauge measuringcontraction and/or relaxation of the cardia 204.

The device as shown in FIG. 2a further comprises a second conduit 222for backflow of hydraulic fluid. The backflow is adapted to create thedesired feeling of satiety for a predetermined time whereafter thehydraulic fluid has flowed back in a quantity large enough for thestretching device not to stretch the stomach wall anymore and therebythe feeling of hunger returns to the patient. A suitable time for theprocess is between 1 and 6 hours. According to other embodiments thebackflow takes place in the main conduit 18 by means of a valve systemconnected to said conduit 18.

For filling and calibrating the fluid level of the device an injection1001 port is furthermore provided. The injection port 1001 preferablycomprises self sealing membrane, such as a silicone membrane.

FIG. 2b shows the device according to the embodiment of FIG. 2a , in asecond state in which the stretching device 10 is expanded and therebystretches the stomach wall 12.

FIG. 3a shows an embodiment, wherein two stretching devices 10″ areprovided. Both stretching devices 10″ work according to the principlesdescribed above with reference to FIG. 1. They can be adapted topostoperatively and non-invasively be regulated and adapted to from timeto time regulate different stretching devices to at a first time stretcha first part of the stomach wall and at a second time stretch a secondpart of the stomach wall.

Such a stretching device 10 may be used for keeping electronics and/oran energy source and/or hydraulic fluid. Hydraulic fluid from thatdevice may be distributed to several smaller stretching device areas tovary the stretching area from time to time avoiding any possible morepermanent stretching effect of the stomach wall. Even mechanicallyseveral stretching areas may be used. The embodiment according to FIG.3a further comprises a hydraulic valve shifting device 54, implanted inthe patient, for shifting between operating the first and the secondstretching device 10″. The alternating creates a more sustainable devicesince the receptors in the stomach wall is stimulated gets a longer timeof recovery between the stretches.

In FIG. 3a the system is a manual system controlled by the patient asdescribed before with reference to FIG. 1, whereas in FIG. 3b the systemis energized using wireless energy as described before with reference toFIG. 2 a.

FIG. 4a-e shows different embodiments of the si etching device 10adapted to be implanted in a patient. The stretching device 10 comprisesa surface adapted to be in contact with the stomach wall 12 when thedevice is invaginated in the stomach wall, FIG. 4b shows an embodimentof the stretching device in which the stretching device comprises afixating member 206 for suturing or stapling, the stretching device tothe stomach wall. The fixating member 206 could comprise holes forreceiving said sutures or staplers 14, or the fixation device 206 couldbe per such that the sutures or staplers can penetrate the stomach walland the fixation device 206. 4 c shows the stretching device 10according to an embodiment in which the stretching device 10 comprisesan inlet member 207 for filling said device with a fluid. Said inletmember is preferably connected to a hydraulic conduit 18 adapted to beinvaginated in the stomach wall 12. FIG. 4d shows the stretching device10 according to an embodiment in which the stretching device 10comprises a holding member 208 adapted to connect to an insertion devicewhen said stretching device 10 is inserted into an invaginated pouch ofthe stomach wall 12. FIG. 4e shows the stretching device 10 according toan embodiment in which the stretching device has a slightly oval oregg-shaped shape. FIG. 4e furthermore shows the hydraulic conduit 18attached to said stretching device 10. FIG. 4f shows the stretchingdevice 10 according to an embodiment in which the stretching device isinflatable by a fluid transported through the conduit 18. According toone embodiment shown in FIG. 4f the conduit comprises two sections 18a,b wherein the first section 18 a is used to pull the stretching device10 into place, and to fill the device 10 with a suitable fluid, whereasthe second section 18 b is used for the operation of said device 10.FIG. 4g shows the stretching device 10 according to the embodiment ofFIG. 4f in a deflated state. The stretching device 10 is insertedthrough a hole in the stomach wall 12 in its deflated state whereafterthe device 10 is filled with a suitable fluid for operation. FIG. 4hshows the stretching device 10 according to an embodiment in which thestretching device 10 comprises two movable wall portion 223 a,b, whichare moveable by means of a bellows structure 209 made of a flexiblematerial. FIG. 4i shows the stretching device according to an embodimentwhere the stretching device is expandable by means of four expandablesections 210 symmetrically placed on four places along the surface ofthe stretching device, as shown in the section image of FIG. 4i . Theexpandable sections 210 are made of a flexible material for allowingsaid sections 210 to expand when said stretching device 10 is filledwith a hydraulic fluid.

A first distance 708 a between two elevated areas 701, see FIG. 5a , islong enough so us to prevent growth of fibrotic tissue directlyconnecting two adjacent elevated areas 707. That is, it may be possiblethat fibrotic tissue grows on the surface of the elevated and loweredareas 701, 702 and the connecting areas 704. However, thanks to theextension of the first distance 708 a, fibrotic tissue is prevented fromgrowing directly from one elevated area 701 to another adjacent elevatedarea 701.

With the expression “growing directly from one elevated area 701 toanother elevated area 701” it is e.g. meant that fibrotic tissue growsfrom one elevated area 701 to another while not or only to a smallextent growing on a connecting area 704. As indicated at 704 a in FIG.5i , the first distance 708 a may be measured within an interval 704 afrom the level of an elevated area 701. The expression “growing directlyfrom one elevated area 701 to another elevated area 701” also includesthe situation that fibrotic tissue grows on adjacent areas, e.g. twoadjacent connecting areas 704, with such a thickness that the fibrotictissue from each adjacent area meet and bridge the distance or spacebetween two elevated areas 701. In such a situation the space betweentwo elevated areas 701 may be partly or completely filled with fibrotictissue.

It may be advantageous that also a second distance 708 b correspondingto the extension of a lowered area 702 has an extension great enough soas to prevent fibrotic tissue from growing directly from one connectingarea 704 to another connecting area 704. With the expression “growingdirectly from one connecting area 704 to another connecting area 704” itis meant that fibrotic tissue grows from one connecting area 704 toanother while not or only to a small extent growing on a lowered area702.

In FIG. 5a surface structure comprising elevated and lowered areas hasbeen shown, but apart from elevated and lowered areas also many othergeometrical structures may be used where it is possible to fulfill theabove mentioned prevention of growth of fibrotic tissue. In particular,the above mentioned prevention of growth of fibrotic tissue betweenelevated areas and between connecting areas.

Some examples of such other geometrical structures are shown in FIGS.5i-5k . In a surface structure comprising ridges and grooves, the ridgesand grooves may also have different sections, some examples are shown inFIGS. 5a -5 e.

Referring mainly to FIGS. 5a and 5b some expressions and aspects willnow be explained. In this application the concept of a first distance708 a, 718 a between adjacent elevated areas 701, 710 is used. With sucha first distance 708 a, 718 a it is meant a distance that is measuredsubstantially from the edge 706, 714 of one elevated area 701, 710 tothe edge 706, 714 of an adjacent elevated area 701, 710. Measuredsubstantially from the edge means that the measurement may be donewithin a first interval 704 a from the level of an elevated area 701,710, the first interval 704 a extending from the level of an elevatedarea 701, 710 towards the level of an adjacent lowered area 702, 712.

In this application also the concept of a second distance 708 b, 718 bbetween adjacent connecting areas 704, 716 is used. With such a seconddistance 708 b, 718 b it is meant a distance that is measuredsubstantially from the connection point between a connecting area 704,716 and a lowered area 702, 712 to another connection point involving anadjacent connecting area 704, 716. Measured substantially from theconnection point means that the measurement may be done within a secondinterval 704 b from the level of a lowered area 702, 712, the secondinterval 704 b extending from the level of a lowered area 702, towardsthe level of an adjacent elevated area 701, 710.

With elevated and lowered areas it is meant areas that lie in differentplanes 703, 705, 720, 722 where the planes are separated by a distance707, 724, 728. The planes may be parallel or substantially parallel butmay also be non-parallel. If the planes are parallel, defining adistance between them is trivial. If the planes are non-parallel (as inFIG. 5b ) a distance between the planes may be defined by a normal 724,728 to one of the planes 720, 722 where the normal extend to a point onan area in another plane 722, 726 and the distance between the planes isequal to the extension of the normal 724, 728. As seen in FIG. 5b thenormal 724, 728 extends from a plane 720, 722 to a point which isapproximately equally distant from the edges of an area. There are twopossible ways to define the normal or distance between the planes.Taking normal 728 as example, one may define the normal as in 728 a orin 728 b. It may be suitable to define the distance between two planesas the extension of the longest normal, the distance between the planes720 and 722 would then be equal to the extension of normal 728 a. Thisdefinition will be used hereafter.

The elevated and lowered areas may have different shapes, they may beplane or substantially plane but they may also have some kind of curvedshape.

The elevated areas 701, 710 connect to adjacent lowered areas 702, 712by means of connecting areas 704, 716. The connection betweenelevated/lowered areas and connecting areas 704, 716 may comprise aradius of different sizes, bigger or smaller radii. When the radius isvery small there will substantially be an edge 706, 714 connecting theareas.

The expression “expandable section” implies that said section alsocollapsible.

Suitably the stretching device 10 at least partly comprises materialswhich have a high degree of biocompatibility, such materials may becalled physiologically inert, biologically inert or biocompatible.

Referring in particular to FIGS. 5a and 5b , in the surface structure700 there may advantageously be a specified first distance 708 a, 718 abetween adjacent elevated areas 701, 710. The distance between adjacentelevated areas 701, 710 is chosen so that fibrotic tissue cannot bridgethe first distance 708 a, 718 a between adjacent elevated areas 701,710. Hence, the first distance 708 a, 718 a between adjacent elevatedareas 701, 710 is advantageously big enough to prevent the formation offibrotic tissue that bridges adjacent elevated areas 701, 710.

As mentioned before, there may advantageously be a specified seconddistance 708 b, 718 b between adjacent connecting areas 704, 716. Thesecond distance 708 b, 718 b between adjacent connecting areas 704, 716is chosen so that fibrotic tissue can not bridge the second distance 708b, 718 b between adjacent connecting areas 704, 716. Hence, the seconddistance 708 b, 718 b between adjacent connecting areas 704, 716 isadvantageously big enough to prevent the formation of fibrotic tissuethat bridges adjacent connecting areas 704, 716.

It may also be advantageous that a third distance 707, 724, 728 abetween the different planes 703, 705, 720, 722, 726 of the elevated andlowered areas is bigger than a certain threshold to facilitate thecollapsible and/or expandable functionality of the stretching device. Ifthe third distance 707, 724, 728 a is too small the collapsible and/orexpandable functionality of the stretching device may be limited. Asuitable interval for the third distance 707, 724, 728 a is 0.5 to 10mm, more suitable 2-8 mm and most suitable 3-7 mm. Also regarding theaspect that the fibrotic tissue should not impede thecollapsible/expandable functionality of the stretching device it isadvantageous that the distance 707, 724, 728 a is not too small, butsuitably in the interval/s as mentioned previously.

The surface structure 700 may include objects or elements of differentgeometrical shapes, for example ridges of different shapes, embossmentsof different shapes and other objects which enable a surface structureas described herein. The area of the elevated areas 701, 710 may be verysmall while still resulting in a surface structure that has the desiredfunctionality. The area of the elevated areas 701, 710 may even bealmost zero, as exemplified in FIG. 5e . Whereas FIGS. 5a and 5b-5e showcross sections of examples of surface structures 700, FIGS. 5i-5k showexamples of different surface structures 700 in perspective. The objectsor elements in the surface structure 700 may be placed in rows, orderedin some other way, or may be more or less randomly distributed over thesurface of the stretching device. Different types of objects may also beused together in the surface structure 700, e.g. a combination ofpyramid shaped and cone shaped objects together with ridges of someshape.

In FIGS. 5f-5h an embodiment of a stretching device 10 is shown where asurface structure 700 is used, the stretching device 10 is not shown infull. FIG. 3 shows a longitudinal section of the stretching device 10where 740 denotes the surface structure on the upper side of thestretching device 10 and 742 denotes the surface structure on the underside of the stretching device 10. As shown in FIG. 5f the surfacestructure 742 on the under side may have a greater extension than thesurface structure 740 on the upper side of the penile prosthesis. Thisgives the stretching device 10 an up-bent position when the stretchingdevice 10 is expanded. The surface structures 140 and 142 are oneexample of a bending portion. FIG. 5g shows a cross section of thestretching device 10 where the stretching device 10 includes a waistportion 744, where the waist portion comprises waist surface structures746 and 748. The waist portion with the waist surface structures 746 and748 make the stretching device 10 expandable also in the radialdirection. The stretching device 10 may also have a cross section asshown in FIG. 10 comprising a waist portion 744 having four waistsurface structures 750, 752, 754, 756 further facilitating the abilityof the stretching device 10 to be expandable also in the radialdirection. The cross section in FIG. 5g is taken along the line A1-A2 inFIG. 5 f.

FIG. 6a illustrates a stretching device 10 provided with an inlet port18 b. The stretching device 10 is invaginated in the stomach wall 12 andthe inlet port 18 b is available for connection to a tube or the likefrom the abdominal area of the patient. The tube or conduit 18 canpreferably be connected to the control unit 42 or an injection port1001.

FIG. 6b illustrates an invaginated stretching device 10 wherein, insteadof an inlet port, a conduit 18 or electrical lead extends into theabdominal area of the patient.

FIG. 6c shows a section of the stretching device 10 and part of thestomach in which the stretching device 10 is invaginated. The conduit 18or electric lead is invaginated in the stomach wall 12 by means ofstomach to stomach sutures or staplers 14 which creates an entirelysealed pouch of stomach wall tissue in which the stretching device 10 isplaced. The conduit 18 or electric lead is thereby tunneled in thestomach wall 12 between the inlet port 18 b and the volume fillingdevice 10.

It has been shown that the shape of the stretching device 10 can takemany different forms. It will be appreciated that also the material ofthe stretching device 10 can vary. It is preferred that the stretchingdevice 10 is provided with a coating, such as a Parylene,polytetrafluoroethylene (PTFE), or polyurethane coating, or acombination of such coatings, i.e., a multi-layer coating. This coatingor multi-layer coating improves the properties of the stretching device,such as its resistance to wear.

In another embodiment shown in FIG. 7, the stretching device 110 worksaccording to a different principle from that described above withreference to FIGS. 1-6. The stretching device 110 here comprises a firstfixation portion 110 a adapted to have a first fixation at a firstposition on the stomach wall 12 and a second fixation portion 110 badapted to have a second fixation at a second position on the stomachwall 12. These fixation portions 110 a,b, which preferably have anessentially round shape and preferably are adapted to be invaginated inthe stomach wall 12, are attached to the distal end of a respective leg211, which in turn are attached at their respective proximal end to anoperation device, such as a motor 40. According to the embodiment shownin FIG. 7 the motor is a hydraulic motor, comprising a hydraulic piston,which is connected to a manual operation device described previouslywith reference to FIG. 1. The hydraulic piston affects the legs throughtheir connection with a joint 212 placed in the extremity of the leg.The stretching device 110 is enclosed in a housing 214 protecting thedevice from the in growth of fibrotic tissue which potentially coulddamage the function of said device 110. However it is equallyconceivable that the motor is another hydraulic motor a pneumatic motoror an electrical motor.

The stretching device 110 is adapted to increase the distance betweenthe first position and the second position on the stomach wall 12,thereby stretching the stomach wall 12. The first and/or second fixationportions 110 a, 110 b are adapted to at least partly be invaginated inthe stomach wall 12 with stomach-to-stomach sutures or staplers 14holding the fixation portions 110 a,b in place in suspension in relationto the stomach wall 12.

Of course the first and second positions may be sutured or fixated tothe stomach wall in many possible ways and the invention covers allpossibilities to distend the stomach wall by moving two portions of thestomach wall away from each other and thereby first fixating the deviceto at least two positions on the stomach wall. However, the softsuspended connection to the stomach wall 12 where fibroticstomach-to-stomach tissue helps to give a long term stable position isto prefer.

Of course just expanding an invaginated part of the stomach alsostretches away the stomach wall 12, which also may be achieved bothmechanically, hydraulically, pneumatically and both being powered with amotor or pump or by manual force.

Any kind of mechanical construction may be used and the mechanicalembodiment disclosed is one example. Any mechanical construction drivenby mechanically or hydraulically or any pneumatic construction may beused. Any motor or any pump or moving material changing form whenpowered may be used to achieve the simple goal of stretching a part ofthe stomach wall by moving at least two portions of the stomach wallaway from each other.

FIG. 8 shows the stretching device 110 according to an embodiment inwhich the stretching device is controlled from an implantable controlassembly 42 to which sensor input, as described earlier, in received.The stretching device is then regulated through the conduit 18 using apump 44, connected to at least one fluid reservoir 16, 46, and poweredfrom a energy transforming member 30 connected to an receiver ofwireless energy 205, placed under the skin 36, or an implantable energysource 70, such as a rechargeable battery.

In a variant, shown in FIG. 9a , the first and/or second fixationportions 210 a, 210 b, respectively, exhibit a structure adapted to bein contact with the stomach wall 12 to promote growth in of human tissueto secure the long term placement of the stretching device 110 attachedto the stomach wall 12. This structure preferably comprises a net likestructure 213. The fixation portions 210 a, 210 b may be adapted to keepthe stretching device 110 in place by sutures or staplers between thefixation portion and the stomach wall 12 to secure the short termplacement of the stretching device 110. In turns of mechanical operationthe stretching device 110 according to the embodiment shown in FIG. 9afunctions in accordance with the device described with reference to FIG.7. FIG. 9b shows a fixation device 213 comprising a net like structureadapted to propagate the growth-in of fibrotic tissue to fixate the twofixating portions to the stomach wall 12.

FIG. 9c shows the stretching device according to the embodiment of FIG.9a in a second state, in which the two fixating portions have beenseparated from each other and the stomach 12 has been stretched.

FIG. 10a shows the stretching device according to an embodiment in whichthe stretching device is an electrical mechanical stretching deviceconnected to a control assembly 42 through a power supply line 32′. Thepower supply line 32 is connected to a power transforming device 30 incontact with a receiver of wireless energy 205, such as a coil, whichreceives energy from a transmitter of wireless energy 34 a. The controlassembly may furthermore comprise a battery 70 for storing energyreceived from the wireless energy transmission device 34 a. The controlassembly receives input from a sensor 201, which according to thisembodiment is a strain gauge measuring the contraction and/or relaxationof the cardia 204.

FIG. 10b shows the stretching device 10 in further detail. Thestretching device 10 comprises a housing having a bellows structure 209made of a flexible material so as to enable the wall portions to move.The power supply line 32 is connected to a stator 217 of an electricalmotor, said motor further comprising a rotor 218 which comprises athread that interacts with a displaceable member 219 comprising acorresponding thread. The displacing member is rotatably fixated to ahousing contacting member 220 which pushes against the housing foraffecting the volume of the stretching device and thereby stretching thestomach 12.

FIG. 10c shows the stretching device according to FIG. 10b in a secondstate, in which the stretching device is expanded and thereby stretchesthe stomach wall 12.

FIG. 11a shows an embodiment in which a device adapted to treat refluxdisease is combined with the stretching device according to any of theembodiments above. After invagination of the device 410 in the fundus416, a fixation consisting of a number of stomach-to-stomach sutures orstaples 422 a is applied to keep the invagination intact in the shortterm. A second fixation consisting of a number of sutures or staples 422b is provided to hold the device 410 in position above the cardia 414.The sutures or staples 422 b are applied between the wall of the fundus416 and the wall of the esophagus 424. Additionally, a third fixation inthe form of sutures or staples 422 c may be provided between the wall ofthe fundus 416 and the diaphragm 418, again, to hold the device 410 inposition above the cardia 414.

In this fourth embodiment depicted in FIG. 11a , the size of the refluxdisease treatment device 410 can be regulated while being implanted. Thereflux disease treatment device 410 is associated with a subcutaneoushydraulic reservoir 452 connected to the reflux disease treatment device410, by a lead 452 b whereby a non-invasive regulation can be performedby manually pressing the reservoir 452. Pressing the reservoir 452displaces hydraulic fluid from the reservoir 452 to the smaller chambers410 b via the lead 452 b. The reflux disease treatment device 410 is, inturn, connected to one or more smaller chambers 410 b. In this manner,the patient may adjust the size of the reflux treatment device 410 in amanner adapted to the treatment.

Furthermore, the embodiment above may alternatively be used to alsotreat obesity. The device may, in this embodiment, be adapted to treatobesity by using the volume of the reflux disease body to contain afluid, and further using one or several smaller chambers 410 b connectedto the device body with a pump to be filled with fluid to expand andthereby stretch the fundus wall to create satiety. The small chambers410 b are also adapted to be invaginated to in the fundus stomach wall,and when filled with fluid, an expansion of the stomach occurs thatresults in human sensor feedback creating satiety. The subcutaneoushydraulic reservoir/pump enables the patient to conveniently pumphydraulic fluid to fill the small chambers 410 b to create a feeling ofsatiety as he or she wishes.

An alternative embodiment is shown in FIG. 11b . This embodiment issubstantially similar to the one shown in FIG. 11a but differs in howthe reflux treatment device 410 and chambers 410 b are controlled. Here,the chambers 410 b are not controlled by a subcutaneous pump but apowered internal control unit 456. The internal control unit 456comprises means for the patient to control the device 410 in how itshall be used regarding treatment of reflux and/or obesity. It may alsocomprise means of supplying power to the device.

The internal control unit 456 may comprise a battery 470, an electricswitch 472, a motor/pump 444, a reservoir 452, an injection port 1001.An energy transmission device 34 with a remote control is adapted forcontrolling and powering the device. The items being selected dependingon the circumstances, e.g. if the device is electrically, hydraulically,pneumatically or mechanically operated.

The device 410 may be used for keeping electronics and/or an energysource and/or hydraulic fluid.

FIG. 12a shows an adjustable volume filling device 810, which isinvaginated in the stomach wall of a patient's stomach 12. The volumefilling device 810 is adapted to take up space in the stomach andthereby reduce the volume in which food can be placed. Additionally, anadjustable stretching device 10 according to any of the embodiments isinvaginated in the stomach fundus wall of the patient. It is preferredthat the volume filling device 810 is substantially larger than thestretching device 10.

The volume filling device 810 and the stretching device 10 are in fluidcommunication with each other via a first fluid tube 52, in which a pump54 is provided. The pump 54 is under the control from an energytransforming device 30, which is adapted to supply the pump 54 withenergy via a power supply line 56. The energy transforming device 30 isalso connected to a sensor 201 provided in the esophagus of the patientso that food intake can be detected.

The volume filling device 810 and the stretching device 10 are also influid communication with each other via a second fluid tube 58, whichpreferably has a smaller cross-sectional area than the first fluid tube52.

The operation of this arrangement is as follows. The volume fillingdevice 810 functions as in the above described embodiments, i.e., itreduces the size of the food cavity of the patient's stomach 12.Additionally, when the stretching device 10 is enlarged by pumping fluidfrom the volume filling device 810 and to the stretching device 10 bymeans of the pump 54, the stomach fundus wall is stretched, creating afeeling of satiety for the patient. Thus, for example when food intakeis detected by means of the sensor 201, fluid is automatically pumpedinto the stretching device 10 to increase the feeling of satiety andthereby limit the food intake.

When fluid has been injected into the stretching device 10, the internalpressure therein is higher than the internal pressure in the volumefilling device 810. This difference in pressure will create a flow offluid in the second, preferably narrower tube 58 from the stretchingdevice 10 to the volume filling device 810. The flow rate will bedetermined by among other things the difference in pressure and thecross-sectional area of the second tube 58. It is preferred that thesecond tube is so dimensioned, that the pressures in the volume fillingdevice 810 and the stretching device 10 will return to equilibrium after3 hours after fluid has been injected into the stretching device 10 tocreate the feeling of satiety.

In this embodiment, the function of the second tube 58 is to allow fluidto return front the stretching device 10 to the volume filling device810. It will be appreciated that this function also can be performed bythe pump 54 in the first tube 52 and that the second tube 58 then can beomitted.

Yet an alternative embodiment of a device for treating obesity will nowbe described with reference to FIG. 12b , which shows a stomach 12 of apatient who is treated for obesity. The device comprises a volumefilling device 810 in the form of an inflatable device 10 which isinvaginated in the wall 12 a of the patient's stomach 12. However, inthis case the invagination has been performed in the fundus, i.e., theupper portion of the stomach, where the number of receptors in thestomach wall is large, and the inflatable device functions as astretching device for part of the stomach fundus wall.

A regulation reservoir for fluids is connected to the inflatable deviceby means of a conduit 18 in the form of a tube. The inflatable device810 is thereby adapted to be regulated, preferably non-invasively, bymoving liquid or air from the regulation reservoir to the chamber formedby the inflatable device 810. The regulation of the inflatable device810 preferably comprises a reversed servo, i.e., a small volume isactuated for example by the patient's finger and this small volume is inconnection with a larger volume, i.e., the regulation reservoir.

Thus, the inflatable device 810 is placed outside the stomach wall andis adapted to stretch a part of the stomach fundus wall, therebyaffecting the patient's appetite. By enlarging the size of thestretching device, the stomach fundus wall surrounding the inflatablestretching device 810 is stretched since the circumference of theinflatable stretching device 810 is increased. By this stretching, thereceptors in the stomach wall indicate that the stomach is full, therebycreating a feeling of satiety to the patient. Correspondingly, when thestretching device 810 is contracted, the receptors indicate that thestomach is not full, thereby returning the feeling of hunger. It will beappreciated that this embodiment combines the effects of both reducingthe volume of the stomach food cavity and stretching part of the stomachwall 12, thereby increasing the treatment effect.

The expansion and contraction of the stretching device 810 can beperformed under direct control of the patient. Alternatively, theexpansion and contraction can be performed according to a pre-programmedschedule.

In a preferred embodiment, shown in FIG. 12c , a sensor 201 is providedat a suitable position, such, as at the esophagus. The volume fillingdevice 810 in the form of the inflatable stretching device is similar tothe one shown in FIG. 12b . By providing one or more sensors, the devicefor treating obesity can be automated in that the size of the volumefilling device 810 in the form of the inflatable stretching device isadjusted depending on the amount of food entering the food cavity of thestomach. The fluid is thereby moved between the inflatable volumefilling device 810 and a fluid reservoir.

System

A obesity treatment system, generally designated 28 and comprising astretching device as described above will now be described withreference to FIGS. 13-29

The system of FIG. 8 comprises a stretching device 10 placed in theabdomen of the patient. An internal energy source in the form of animplanted energy transforming device 30 is adapted to supply energyconsuming components of the obesity treatment system with energy via apower supply line 32. An external energy transmission device 34 includesa wireless remote control transmitting a wireless signal, which isreceived by a signal receiver, which may be incorporated in theimplanted energy transforming device 30 or be separated therefrom. Theimplanted energy transforming device 30 transforms energy from thesignal into electric energy which is supplied via the power supply line32.

The system of FIG. 8 is shown in a more generalized block diagram formin FIG. 15, wherein the patient's skin 36, generally shown by a verticalline, separates the interior of the patient to the right of the linefrom the exterior to the left of the line.

FIG. 13 shows a simplified block diagram showing the stretching device10, the energy transforming device 30 powering the stretching device viapower supply line 32, and the external energy transmission device 34.

FIG. 14 shows an embodiment of the invention identical to that of FIG.17, except that a reversing device in the form of an electric switch 38operable by polarized energy also is implanted in the patient forreversing the stretching device 10. The wireless remote control of theexternal energy transmission device 34 transmits a wireless signal thatcarries polarized energy and the implanted energy transforming device 30transforms the wireless polarized energy into a polarized current foroperating the electric switch 38. When the polarity of the current isshifted by the implanted energy transforming device 30 the electricswitch 38 reverses the function performed by the stretching device 10.

FIG. 15 shows an embodiment of the invention identical to that of FIG.13, except that an operation device 40 implanted in the patient forregulating the stretching device 10 is provided between the implantedenergy transforming device 30 and the stretching device 10. Thisoperation device can be in the form of a motor 40, such as an electricservomotor. The motor 40 is powered with energy from the implantedenergy transforming device 30, as the remote control of the externalenergy transmission device 34 transmits a wireless signal to thereceiver of the implanted energy transforming device 30.

FIG. 16 shows an embodiment of the invention identical to that of FIG.17, except that it also comprises an operation device is in the form ofan assembly 42 including a motor/pump unit 78 and a fluid reservoir 46is implanted in the patient. In this case the stretching device 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 44 from the fluid reservoir 46 through a conduit 48 to thestretching device 10 to operate the stretching device, and hydraulicfluid is pumped by the motor/pump unit 44 back from the stretchingdevice 10 to the fluid reservoir 46 to return the stretching device to astarting position. The implanted energy transforming device 30transforms wireless energy into a current, for example a polarizedcurrent, for powering the motor/pump unit 44 via an electric powersupply line 50.

Instead of a hydraulically operated stretching device 10, it is alsoenvisaged that the operation device comprises a pneumatic operationdevice. In this ease, pressurized air can be used for regulation and thefluid reservoir is replaced by an air chamber and the fluid is replacedby air.

In all of these embodiments the energy transforming device 30 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the device.

The external energy transmission device 34 is preferably wireless andmay include a remotely controlled control device for controlling thedevice from outside the human body.

Such a control device may include a wireless remote control as well as amanual control of any implanted part to make contact with by thepatient's hand most likely indirect for example a button to press placedunder the skin.

FIG. 17 shows an embodiment of the invention comprising the externalenergy transmission device 34 with its wireless remote control, thestretching device 10, in this ease hydraulically operated, and theimplanted energy transforming device 30, and further comprising ahydraulic fluid reservoir 52, a motor/pump unit 44 and an reversingdevice in the form of a hydraulic valve shilling device 54, allimplanted in the patient. Of course the hydraulic operation could easilybe performed by just changing the pumping direction and the hydraulicvalve may therefore be omitted. The remote control may be a deviceseparated from the external energy transmission or included in the same.The motor of the motor/pump unit 44 is an electric motor. In response toa control signal from the wireless remote control of the external energytransmission device 34, the implanted energy transforming device 30powers the motor/pump unit 44 with energy from the energy carried by thecontrol signal, whereby the motor/pump unit 44 distributes hydraulicfluid between the hydraulic fluid reservoir 52 and the stretching device10. The remote control of the external energy transmission device 34controls the hydraulic valve shilling device 54 to shill the hydraulicfluid flow direction between one direction in which the fluid is pumpedby the motor/pump unit 44 from the hydraulic fluid reservoir 52 to thestretching device 10 to operate the stretching device, and anotheropposite direction in which the fluid is pumped by the motor/pump unit44 back from the stretching device 10 to the hydraulic fluid reservoir52 to return the stretching device to a starting position.

FIG. 18 shows an embodiment of the invention identical to that of FIG.17, except that an internal control unit 56 controlled by the wirelessremote control of the external energy transmission device 34, anaccumulator 58 and a capacitor 60 also are implanted in the patient. Theinternal control unit 56 arranges storage of electric energy receivedfrom the implanted energy transforming device 30 in the accumulator 58,which supplies energy to the stretching device 10. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 either releaseselectric energy from the accumulator 58 and transforms the releasedenergy via power lines 62 and 64, or directly transforms electric energyfrom the implanted energy transforming device 30 via a power line 66,the capacitor 60, which stabilizes the electric current, a power line 68and the power line 64, for the operation of the stretching device 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the stretching device 10 to stretch the stomachaccording to a pre-programmed time-schedule or to input from any sensorsensing any possible physical parameter of the patient or any functionalparameter of the device.

In accordance with an alternative, the capacitor 60 in the embodiment ofFIG. 18 may be omitted. In accordance with another alternative, theaccumulator 58 in this embodiment may be omitted.

FIG. 19 shows an embodiment of the invention identical to that of FIG.13, except that a battery 70 for supplying energy for the operation ofthe stretching device 10 and an electric switch 72 for switching theoperation of the stretching device 10 also is implanted in the patient.The electric switch 72 is operated by the energy supplied by theimplanted energy transforming device 30 to switch from an off mode, inwhich the battery 70 is not in use, to an on mode, in which the battery70 supplies energy for the operation of the stretching device 10.

FIG. 20 shows an embodiment of the invention identical to that of FIG.19, except that an internal control unit 56 controllable by the wirelessremote control of the external energy transmission device 34 also isimplanted in the patient. In this ease, the electric switch 72 isoperated by the energy supplied by the implanted energy transformingdevice 30 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 56 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 56 to releaseelectric energy from the battery 70 for the operation of the stretchingdevice 10.

FIG. 21 shows an embodiment of the invention identical to that of FIG.20, except that an accumulator 58 is substituted for the battery 70 andthe implanted components are interconnected differently. In this case,the accumulator 58 stores energy from the implanted energy transformingdevice 30. In response to a control signal from the wireless remotecontrol of the external energy transmission device 34, the internalcontrol unit 56 controls the electric switch 72 to switch from an offmode, in which the accumulator 58 is not in use, to an on mode, in whichthe accumulator 58 supplies energy for the operation of the stretchingdevice 10.

FIG. 22 shows an embodiment of the invention identical to that of FIG.21, except that a battery 70 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the external energytransmission device 34, the internal control unit 56 controls theaccumulator 58 to deliver energy for operating the electric switch 72 toswitch from an off mode, in which the battery 70 is not in use, to an onmode, in which the battery 70 supplies electric energy for the operationof the stretching device 10.

Alternatively, the electric switch 72 may be operated by energy suppliedby the accumulator 58 to switch from an off mode, in which the wirelessremote control is prevented from controlling the battery 70 to supplyelectric energy and is not in use, to a standby mode, in which thewireless remote control is permitted to control the battery 70 to supplyelectric energy for the operation of the stretching device 10.

It should be understood that the switch should be interpreted in itsbroadest embodiment. This means an FPGA or a DA converter or any otherelectronic component or circuit may switch power on and off preferablybeing controlled from outside the body or by an internal control unit.

FIG. 23 shows an embodiment of the invention identical to that of FIG.19, except that a motor 40, a mechanical reversing device in the form ofa gear box 74, and an internal control unit 56 for controlling the gearbox 74 also is implanted in the patient. The internal control unit 56controls the gear box 74 to reverse the function performed by thestretching device 10 (mechanically operated). Even simpler is to switchthe direction of the motor electronically.

FIG. 24 shows an embodiment of the invention identical to that of FIG.22 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 56 is powered by thebattery 70 when the accumulator 58, suitably a capacitor, activates theelectric switch 72 to switch to an on mode. When the electric switch 72is in its on mode the internal control unit 56 is permitted to controlthe battery 70 to supply, or not supply, energy for the operation of thestretching device 10.

FIG. 25 schematically shows conceivable combinations of implantedcomponents of the device for achieving various communication options.Basically, there are the stretching device 10, the internal control unit56, motor or pump unit 44, and the external energy transmission device34 including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the internal control unit 56, which in turn controls thevarious implanted components of the device.

A feedback device, preferably in the form of a sensor 76, may beimplanted in the patient for sensing a physical parameter of thepatient, such as a contraction wave in the esophagus 203 informing thepatient is eating. The internal control unit 56, or alternatively theexternal wireless remote control of the external energy transmissiondevice 34, may control the stretching device 10 in response to signalsfrom the sensor 76. A transceiver may be combined with the sensor 76 forsending information on the sensed physical parameter to the externalwireless remote control. The wireless remote control may comprise asignal transmitter or transceiver and the internal control unit 56 maycomprise a signal receiver or transceiver. Alternatively, the wirelessremote control may comprise a signal receiver or transceiver and theinternal control unit 56 may comprise a signal transmitter ortransceiver. The above transceivers, transmitters and receivers may beused for sending information or data related to the stretching device 10from inside the patient's body to the outside thereof.

Alternatively, the sensor 76 may be arranged to sense a functionalparameter of the stretching device 10.

Where the motor/pump unit 44 and battery 70 for powering the motor/pumpunit 44 are implanted, the battery 70 may be equipped with a transceiverfor sending information on the condition of the battery 70. To be moreprecise, when charging a battery or accumulator with energy feedbackinformation related to said charging process is sent and the energysupply is changed accordingly.

FIG. 26 shows an alternative embodiment wherein the stretching device 10is regulated from outside the patient's body. The obesity treatmentsystem 28 comprises a stretching device 10 connected to a battery 70 viaa subcutaneous switch 80. Thus, the regulation of the stretching device10 is performed non-invasively by manually pressing the subcutaneousswitch, whereby the operation of the stretching device is switched onand off. It will be appreciated that the shown embodiment is asimplification and that additional components, such as an internalcontrol unit or any other part disclosed in the present application canbe added to the obesity treatment system.

FIG. 27 shows an alternative embodiment, wherein the obesity treatmentsystem 28 comprises a stretching device 10 in fluid connection with ahydraulic fluid reservoir 52. Non-invasive regulation is performed bymanually pressing the hydraulic reservoir connected to the stretchingdevice 10.

A further embodiment of a system according to the invention comprises afeedback device for sending information horn inside the patient's bodyto the outside thereof to give feedback information related to at leastone functional parameter of the stretching device or system or aphysical parameter of the patient, thereby optimizing the performance ofthe system.

One preferred functional parameter of the device is correlated to thetransfer of energy for charging the internal energy source.

In FIG. 28, an arrangement is schematically illustrated for supplying anaccurate amount of energy to a obesity treatment system 28 implanted ina patient, whose skin 36 is indicated by a vertical line. A stretchingdevice 10 is connected to an implanted energy transforming device 30,likewise located inside the patient, preferably just beneath thepatient's skin 36. Generally speaking, the implanted energy transformingdevice 30 may be placed in the abdomen, thorax, muscle fascia (e.g. inthe abdominal wall), subcutaneously, or at any other suitable location.The implanted energy transforming device 30 is adapted to receivewireless energy E transmitted from an external energy source 34 aprovided in the external energy transmission device 34 located outsidethe patient's skin 36 in the vicinity of the implanted energytransforming device 30.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 34 a and an adjacent secondary coil arranged inthe implanted energy transforming device 30. When an electric current isfed through the primary coil, energy in the form of a voltage is inducedin the secondary coil which can be used to operate a stretching device,e.g. after storing the incoming energy in an energy storing device oraccumulator, such as a battery or a capacitor. However, the presentinvention is generally not limited to any particular energy transfertechnique, TET devices or energy storing devices, and any kind ofwireless energy may be used.

The amount of energy received inside the body to the device may becompared with the energy used by the device. The term used by the deviceis then understood to include also energy stored by the device. Theamount of transferred energy can be regulated by means of an externalcontrol unit 34 b controlling the external energy source 34 a based onthe determined energy balance, as described above. In order to transferthe correct amount of energy, the energy balance and the required amountof energy can be determined by means of an internal control unit 56connected to the stretching device 10. The internal control unit 56 maythus be arranged to receive various measurements obtained by suitablesensors or the like, not shown, measuring certain characteristics of thestretching device 10, somehow reflecting the required amount of energyneeded for proper operation of the stretching device 10. Moreover, thecurrent condition of the patient may also be detected by means ofsuitable measuring devices or sensors, in order to provide parametersreflecting the patient's condition. Hence, such characteristics and/orparameters may be related to the current state of the stretching device10, such as power consumption, operational mode and temperature, as wellas the patient's condition reflected by, e.g., body temperature, bloodpressure, heartbeats and breathing.

Furthermore, an energy storing device or accumulator 58 may optionallybe connected to the implanted energy transforming device 30 foraccumulating received energy for later use by the stretching device 10.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a battery, and the measuredcharacteristics may be related to the current state of the battery, suchas voltage, temperature, etc. In order to provide sufficient voltage andcurrent to the stretching device 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy transforming device 30, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 56. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 56 is adapted to determine the energybalance and/or the currently required amount of energy, (either energyper time unit or accumulated energy) based on measurements made by theabove-mentioned sensors or measuring devices on the stretching device10, or the patient, or an energy storing device if used, or anycombination thereof. The internal control unit 56 is further connectedto an internal signal transmitter 82, arranged to transmit a controlsignal reflecting the determined required amount of energy, to anexternal signal receiver 34 c connected to the external control unit 34b. The amount of energy transmitted from the external energy source 34 amay then be regulated in response to the received control signal.

Alternatively, sensor measurements can be transmitted directly to theexternal control unit 34 b wherein the energy balance and/or thecurrently required amount of energy can be determined by the externalcontrol unit 34 b, thus integrating the above-described function of theinternal control unit 56 in the external control unit 34 b. In thatcase, the internal control unit 56 can be omitted and the sensormeasurements are supplied directly to the internal signal transmitter 82which sends the measurements over to the external signal receiver 34 cand the external control unit 34 b. The energy balance and the currentlyrequired amount of energy can then be determined by the external controlunit 34 b based on those sensor measurements.

Hence, the present solution employs the feedback of informationindicating the required energy, which is more efficient than previoussolutions because it is based on the actual use of energy that iscompared to the received energy, e.g. with respect to the amount ofenergy, the energy difference, or the energy receiving rate as comparedto the energy rate used by the stretching device. The stretching devicemay use the received energy either for consuming or for storing theenergy in an energy storage device or the like. The different parametersdiscussed above would thus be used if relevant and needed and then as atool for determining the actual energy balance. However, such parametersmay also be needed per se for any actions taken internally tospecifically operate the stretching device.

The internal signal transmitter 82 and the external signal receiver 34 cmay be implemented as separate units using suitable signal transfermeans, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 82 and the externalsignal receiver 34 c may be integrated in the implanted energytransforming device 30 and the external energy source 34 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

To conclude, the energy supply arrangement illustrated in FIG. 28 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 56. A control signal reflectingthe required amount of energy is also created by the internal controlunit 56, and the control signal is transmitted from the internal signaltransmitter 82 to the external signal receiver 34 c. Alternatively, theenergy balance can be determined by the external control unit 34 binstead depending on the implementation, as mentioned above. In thatcase, the control signal may carry measurement results from varioussensors. The amount of energy emitted from the external energy source 34a can then be regulated by the external control unit 34 b, based on thedetermined energy balance, e.g. in response to the received controlsignal. This process may be repeated intermittently at certain intervalsduring ongoing energy transfer, or may be executed on a more or lesscontinuous basis during the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 34 a, suchas voltage, current, amplitude, wave frequency and pulsecharacteristics.

A method is thus provided for controlling transmission of wirelessenergy supplied to an electrically operable stretching device implantedin a patient. The wireless energy E is transmitted from an externalenergy source located outside the patient and is received by an internalenergy receiver located inside the patient, the internal energy receiverbeing connected to the stretching device for directly or indirectlysupplying received energy thereto. An energy balance is determinedbetween the energy received by the internal energy receiver and theenergy used for the stretching device. The transmission of wirelessenergy E from the external energy source is then controlled based on thedetermined energy balance.

A system is also provided for controlling transmission of wirelessenergy supplied to an electrically operable stretching device implantedin a patient. The system is adapted to transmit the wireless energy Efrom an external energy source located outside the patient which isreceived by an implanted energy transforming device located inside thepatient, the implanted energy transforming device being connected to thestretching device for directly or indirectly supplying received energythereto. The system is further adapted to determine an energy balancebetween the energy received by the implanted energy transforming deviceand the energy used for the stretching device, and control thetransmission of wireless energy E from the external energy source, basedon the determined energy balance.

The functional parameter of the device is correlated to the transfer ofenergy for charging the internal energy source.

In yet an alternative embodiment, the external source of energy iscontrolled from outside the patient's body to release electromagneticwireless energy, and released electromagnetic wireless energy is usedfor operating the stretching device.

In another embodiment, the external source of energy is controlling fromoutside the patient's body to release non-magnetic wireless energy, andreleased non-magnetic wireless energy is used for operating thestretching device.

Those skilled in the art will realize that the above various embodimentsaccording to FIGS. 17-29 could be combined, in many different ways. Forexample, the electric switch 38 operated by polarized energy could beincorporated in any of the embodiments of FIGS. 11, 18-24, the hydraulicvalve shifting device 54 could be incorporated in the embodiment of FIG.16, and the gear box 74 could be incorporated in the embodiment of FIG.15. Please observe that the switch simply could mean any electroniccircuit or component.

Wireless transfer of energy for operating the stretching device has beendescribed to enable non-invasive operation. It will be appreciated thatthe stretching device can be operated with wire bound energy as well.One such example is shown in FIG. 29, wherein an external switch 84 isinterconnected between the external energy source 34 a and an operationdevice, such as an electric motor regulating the stretching device 10,by means of power lines 86 and 88. An external control unit 34 bcontrols the operation of the external switch to effect proper operationof the stretching device 10.

Hydraulic or Pneumatic Powering

FIGS. 30-33 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering a device for treating obesityaccording to the invention.

FIG. 30 shows a device for treating obesity as described above withreference to any of FIGS. 1-6. The device comprises a stretching device10 and further a separate regulation reservoir 16, a one way pump 44 andan alternate valve 54.

FIG. 31 shows the stretching device 10 and a fluid reservoir 16. Bymoving the wall of the regulation reservoir or changing the size of thesame in any other different way, the adjustment of the stretching devicemay be performed without any valve, just free passage of fluid any timeby moving the reservoir wall.

FIG. 32 shows the stretching device 10, a two way pump 44 and theregulation reservoir 16.

FIG. 33 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 16 and a servo reservoir 90. The servoreservoir 90 mechanically controls a stretching device 10 via amechanical interconnection 94, the stretching device having anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 92 in fluid connection with the stretching device 10.Alternatively, the cavity contains compressible gas, which can becompressed and expanded under the control of the servo reservoir 90.

The servo reservoir 90 can also be part of the stretching device itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin 36 and is operated by pushing the outer surfacethereof by means of a finger. This obesity treatment system isillustrated in FIGS. 34a-c . In FIG. 34a , a flexible subcutaneousregulation reservoir 16 is shown connected to a bulge shaped servoreservoir 90 by means of a conduit 18. This bellow shaped servoreservoir 90 is comprised in a flexible stretching device 10. In thestate shown in FIG. 34a , the servo reservoir 90 contains a minimum offluid and most fluid is found in the regulation reservoir 16. Due to themechanical interconnection between the servo reservoir 90 and thestretching device 10, the outer shape of the stretching device iscontracted, i.e., it occupies less than its maximum volume. This maximumvolume is shown with dashed lines in the figure.

FIG. 34b shows a state wherein a user, such as the patient in with thestretching device is implanted, presses the regulation reservoir 16 sothat fluid contained therein is brought to flow through the conduit 18and into the servo reservoir 90, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the stretchingdevice 10 so that it occupies its maximum volume, thereby stretching thestomach wall (not shown) which it contacts.

The regulation reservoir 16 is preferably provided with means forkeeping its shape after compression. This means, which is schematicallyshown as 16 a in the figure, will thus keep the stretching device 10 ina stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the obesity treatment system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 35 and 36 a-c. The block diagramshown in FIG. 35 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir16 and a servo reservoir 90. The servo reservoir 90 mechanicallycontrols a larger adjustable reservoir 92 via a mechanicalinterconnection 94. A stretching device 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 92 by supply of hydraulic fluid from the largeradjustable reservoir 92 in fluid connection with the stretching device10.

An example of this embodiment will now be described with reference toFIG. 36a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 16 is in fluid connection with a bellow shaped servo reservoir90 by means of a conduit 18. In the first closed system 16, 18, 90 shownin FIG. 34a , the servo reservoir 90 contains a minimum of fluid andmost fluid is found in the regulation reservoir 16.

The servo reservoir 90 is mechanically connected to a larger adjustablereservoir 92, in this example also having a bellow shape but with alarger diameter than the servo reservoir 90. The larger adjustablereservoir 92 is in fluid connection with the stretching device 10. Thismeans that when a user pushes the regulation reservoir 16, therebydisplacing fluid from the regulation reservoir 16 to the servo reservoir90, the expansion of the servo reservoir 90 will displace a largervolume of fluid from the larger adjustable reservoir 92 to thestretching device 10. In other words, in this reversed servo, a smallvolume in the regulation reservoir is compressed with a higher force andthis creates a movement of a larger total area with less force per areaunit.

Like in the previous embodiment described above with reference to FIGS.34a-c , the regulation reservoir 16 is preferably provided with meansfor keeping its shape after compression. This means, which isschematically shown as 16 a in the figure, will thus keep the stretchingdevice 10 in a stretched position also when the user releases theregulation reservoir. In this way, the regulation reservoir essentiallyoperates as an on/off switch for the obesity treatment system.

Method

A method for surgically treating an obese patient, the method comprisingthe steps of cutting an opening, in the abdominal wall of the patient,dissecting an area around the stomach, placing a device for treating toa part of the stomach wall of the patient, and suturing the stomachwall.

The device for treating obesity is preferably placed in a patient via alaparoscopic abdominal approach, comprising the steps of: inserting aneedle or a tube like instrument into the abdomen of the patient's body,using the needle or a tube like instrument to fill the patient's abdomenwith gas thereby expanding the patient's abdominal cavity, placing atleast two laparoscopic trocars in the patient's body, inserting a camerathrough one of the laparoscopic trocars into the patient's abdomen,inserting at least one dissecting tool through one of said at least twolaparoscopic trocars and dissecting an intended placement area of thepatient, and placing a device for treating obesity in connection withthe stomach wall.

The methods could further comprise the step of postoperativelyregulating the at least one stretching device to: stretch a part of thestomach wall and regulate the stretching device from outside thepatient's body to affect the appetite of the patient.

Instruments

An intraluminar method of invaginating a stretching device 10 on theoutside of the stomach wall 12 will now be described with reference toFIGS. 5a-i . Initially, an instrument 600, preferably a gastroscopicinstrument, is inserted into the mouth of the patient, see FIG. 5a . Theinstrument comprises an injection device 601, 602 for injecting eitherfluid or a device into the stomach of the patient. The instrument 600further comprises a control unit 606 adapted for controlling theoperation of the instrument. To this end, the control unit 606 comprisesone or more steering devices, in the embodiment shown in the figure inthe form of two joysticks 603 and two control buttons 604. A display 605is provided for displaying the image provided by an optical device forviewing inside the stomach, such as a camera (not shown) arranged at theouter end of the elongated member 607, see FIGS. 5e-i . The camera,which may comprise connecting electrical wires extending along theelongated member, may be assisted by a light source (not shown) placeddistally on the elongated member for illuminating the inside of thestomach. The optical device may also comprise optical fibers placedalong the elongated member and leading out from the patient's body forexternal viewing of the inside of the stomach.

The instrument is further inserted into the esophagus and into thestomach of the patient sees FIG. 37b . By means of the instrument 600, ahole 12 b is created in the wall of the stomach 12. To this end, theinstrument is provided with one or more cutters 615 at the distal endthereof. These cutters can of course be designed in different ways, suchas a toothed drum cutter rotating about the center axis of the tube-likeinstrument.

After cutting a hole in the stomach wall, the distal end of theinstrument 600 is inserted into and through the hole 2 b so that it endsup outside the stomach wall 12 a. This is shown in FIG. 37c , showing aside view of the stomach 12, and FIG. 37d , which is a sectional viewthrough the stomach of FIG. 37c taken along the lines Vd-Vd.

The instrument 600 is adapted to create a “cavity” or “pouch” on theoutside of the stomach around the hole 12 h in the stomach wall 12. Suchan instrument and the method of providing the pouch will now bedescribed.

FIGS. 37e-i show a gastroscopic or laparoscopic instrument forinvaginating a stretching device 10 in the stomach wall 12 of thepatient by creating a pouch of stomach wall 12 material in which thestretching device 10 is placed. The instrument, generally designated600, and which may comprise the features described above with referenceto FIGS. 4a-d , comprises an elongated member 607 having a proximal endand a distal end, the elongated member 607 having a diameter less thanthat of the patient's esophagus and being flexible such as to allowintroduction of the flexible elongated member 607 with its distal endfirst through the patient's throat, esophagus and into the stomach 12 tothe stomach wall 12 a.

The stomach penetration device or cutter 615 is provided on theelongated member 607 at the distal en thereof for penetrating thestomach wall 12 a so as to create a hole in the stomach wall 12 a, toallow introduction of the elongated member 607 through the hole. Thestomach penetration device 615 could be adapted to be operable forretracting said stomach penetration device 615 after the stomach funduswall 12 a has been penetrated, for not further damaging tissue withinthe body. The instrument further comprises a special holding device 609provided on the elongated member 607 on the proximal side to thepenetration device 615.

The elongated member further comprises an expandable member 611 which isadapted to be expanded after the elongated member has penetrated thestomach wall 12 a and thereby assist in the creation of a cavity orpouch adapted to hold the volume filling device 610. The expandablemember 611 may comprise an inflatable circular balloon providedcircumferentially around the distal end portion of the flexibleelongated member 607.

The method steps when invaginating the volume filling device will now bedescribed in detail. After the instrument 600 has been inserted into thestomach 12, the stomach penetration device 615 is placed into contactwith the stomach wall 12, see FIG. 37e . The stomach penetration deviceor cutter 615 is then brought to create the hole 12 b in the stomachwall, whereafter at least the expandable member 611 is brought throughthe hole 12 b in the stomach wall. The special holding device 609 is inthis step brought to a holding state wherein it expands radially so asto form an essentially circular abutment surface to the stomach wall 12,see FIG. 37f . In this way, the insertion of the stomach penetrationdevice 615 and the expandable member 611 through the hole 12 in thestomach wall is limited to the position shown in FIG. 37 f.

The expandable member 611 is then expanded. In the case the expandablemember comprises a balloon or the like, air or other fluid is injectedinto it.

The part of the elongated member 607 comprising the expandable member611 is then retracted in the proximal direction, as indicated by thearrow in FIG. 37g , thereby pulling the stomach wall 612 into a basketor cup like structure created by the special holding device 609.

A suturing or stapling device 608 is further provided, either as adevice connected to the elongated member 607 or as a separateinstrument. The suturing or stapling member comprises a suturing orstapling end 613 which is adapted to close the cavity or pouch by meansof stomach to stomach sutures or staples 14.

In a further step, illustrated in FIG. 37h , an inflatable stretchingdevice 10 is placed in its deflated state in the cup like structure. Thestretching device 10 is then inflated to its inflated or expanded state,see FIG. 37i . This inflation of the stretching device 10 can beaccomplished by injecting a fluid or a gel into the deflated stretchingdevice. It can also be accomplished by injecting a material which isallowed to cure, thereby forming a solid device 10. Thus, the stretchingdevice 10 shown in FIGS. 37h and 37i can illustrate either aballoon-like device which is subsequently filled with fluid or gel oralternatively a material which is simply injected into the cup likestructure formed by the stomach wall 12.

The fluid which is used to fill the stretching device 10 could be anysuitable fluid suitable to fill the stretching device 10, such as a saltsolution. In another embodiment, when this fluid is a fluid which isadapted to be transformed into solid state, the fluid could be liquidpolyurethane.

In order to minimize or entirely eliminate leakage, the fluid isiso-tonic, i.e., it has the same osmolarity as human body fluids.Another way of preventing diffusion is to provide a fluid whichcomprises large molecules, such as iodine molecules.

The stomach-to-stomach sutures or staples 14 are preferably providedwith fixation portions exhibiting a structure, such as a net likestructure, adapted to be in contact with the stomach wall 12 to promotegrowth in of human tissue to secure the long term placement of thestretching device attached to the stomach wall.

Thereby is the inflatable stretching device 10 in its inflated orexpanded state invaginated by a stomach wall portion of the patient onthe outside of the stomach wall 12.

During one or more of the above described steps, the stomach may beinflated with gas, preferably by means of the gastroscopic instrument.

The stretching device 10 described above with reference to FIGS. 37a-ihas been described as an inflatable stretching device. It will beappreciated that it also can be an elastic stretching device with anelasticity allowing compression so as to be inserted into a gastroscopicinstrument and which expands to an expanded state after leaving theinstrument.

In one embodiment, the stretching device 10 comprises an inflatablestretching device 10 expandable to an expanded state. In this case, theinflatable stretching device 10 is provided with an inlet port 18 b fora fluid and is adapted to be connected to a gastroscopic instrument.This embodiment will now be described in detail with reference to FIGS.38a -38 d.

An inflatable stretching device in its non-expanded state is shown inFIG. 38a . It is essentially a balloon-like, deflated stretching device10 having an inlet port 18 b. In this state, the inflatable stretchingdevice 10 has a diameter of a few millimeters at the most, allowing itto be inserted into the stomach through the esophagus of the patient bymeans of a gastroscopic, tube-like instrument 600, or through alaparoscopic trocar in an abdominal laparoscopic method using a tubelike instrument 600 depicted in FIG. 38b . The instrument comprises anouter sleeve 600 a and an inner sleeve 600 b which can be displacedlongitudinally relatively to the outer sleeve. The inner sleeve isprovided with a cutter in the form of a cutting edge 615 at the distalend thereof. This cutting edge can be used for cutting a hole in thestomach wall, as will be explained in detail in the following.

When the instrument reaches a stomach wall, from the inside or outsidethereof, see FIG. 38c , the inner sleeve is brought forward from itsposition in the outer sleeve and into contact with the stomach wall 12a. The cutting edge 615 of the inner sleeve then cuts a hole in thestomach wall so as to allow subsequent insertion of the volume fillingdevice 10 into and through this hole, see FIG. 38d . In order to pushthe stretching device through the hole, a piston 602 may be provided inthe instrument. Thus, the instrument further comprises a piston 602adapted for pushing a deflated stretching device 10 out from a positionin the inner sleeve, this position being shown in FIG. 38b , to aposition outside of the inner sleeve, this being shown in FIG. 35 d.

In order to protect the deflated stretching device 10 from the cuttingedge 615 of the inner sleeve, a further protective sleeve (not shown)can be provided around the stretching device.

FIG. 39a-j shows an instrument for use in a method of engaging astretching device 10 to the stomach wall 12 of a patient. The instrumentis adapted to be inserted through a narrow tube shaped object such as agastroscope, used in an intraluminar procedure, or a laparoscopic trocarused in a laparoscopic procedure. The instrument comprises an elongatedmember 650 which is adapted to be flexible by means of a constructioncomprising multiple ring shaped members, however it is equallyconceivable that said elongated member 650 is adapted to be flexible bymeans of said elongated member 650 being made of a flexible oradjustable material. The elongated member 650 is inserted into the bodyand placed in proximity to the stomach wall 12 of the patient, from theoutside or inside thereof. The elongated member 650 has a specialholding device 651 adapted to hold the stomach by means of mechanicalgabbing members or vacuum. The special holding device 651 comprises afirst joint 652 and a second joint 653, which enables the specialholding device 651 be operable in relation to the elongated member 650and thereby place the part of the holding device 651 comprising themechanical grabbing members or vacuum elements in contact with thestomach wall 12 of the patient. FIG. 39b shows the special holdingdevice 651 when placed in contact with the stomach wall 12 of the humanpatient, after which the special holding member 651 connects to thestomach wall 12, for holding the stomach wall 12. FIG. 39c shows theinstrument when the step of advancing a pushing rod 654 from theelongated member 650 is performed. The pushing rod 654 pushes thestomach wall 12 to create a cavity or pouch thereof. FIG. 39d shows theinstrument turned 90° in relation to FIGS. 39a-c . This view shows thespecial holding members 651 a,b operably attached to two sides of theelongated member 650 and being in contact with the stomach wall 12,holding the stomach wall 12 as the pushing rod 654 pushes to create acavity or pouch. When the pushing rod 654 has pushed the stomach wall 12to a desired position the special holding devices 651 a,b moves towardsthe pushing rod 654 and thereby closes the cavity or pouch.

After the cavity or pouch has been created it needs to be sealed. FIG.39f shows the advancement of a suturing or stapling device 655 from theelongated member 650. The suturing or stapling device 655 is positionedin connection with the stomach wall after which the suturing or staplingdevice commences with the suturing or stapling of the stomach wall 12,creating a seal of stomach to stomach sutures or staplers 14.

The instrument is moved along; the stomach wall 12 of the patient andthereby a cavity or pouch is created and sealed using the instrument, asshown in FIGS. 39g and 39h . When a cavity or pouch or desired size hasbeen created and sealed an inserting member 656 is advanced from theelongated member 650. The inserting member 656 is adapted to insert astretching device 10 being inflatable, as described earlier in thisapplication. After the inserting member 656 has been positioned in thecavity or pouch the stretching device 10 is inserted through theinserting member 656 and into the cavity or pouch by means of apressurized fluid or gas, or a mechanical advancement member pushingsaid inflatable stretching device 10 into the cavity or pouch. Theinsertion member then inflates the inflatable stretching device with afluid or gas and seals of the final section of the pouch using stomachto stomach sutures or staplers 14. The embodiment described explains theprocess of inserting an inflatable stretching device, however it isequally conceivable that the stretching device 10 is expandable by meansof the stretching device 10 being made of an elastic material,

FIG. 40a-f shows an instrument for use in a method of engaging astretching device 10 to the stomach wall 12 of a patient. The instrumentis adapted to be inserted through a narrow tube shaped object such as agastroscope, used in an intraluminar procedure, or a laparoscopic trocarused in a laparoscopic procedure. The instrument comprises an elongatedmember 660 which is adapted to be flexible by means of a constructioncomprising multiple ring shaped members, however it is equallyconceivable that said elongated member 660 is adapted to be flexible bymeans of said elongated member 660 being made of a flexible oradjustable material. The elongated member 660 is inserted into the bodyand placed in proximity to the stomach wall 12 of the patient, from theoutside or inside thereof. The elongated member 660 has multiple specialholding devices 661 adapted to hold the stomach by means of mechanicalgrabbing members or vacuum. The special holding devices 661 are lockedin a position alongside the elongated member 660 by means of a lockingring 662. The special holding devices are made of a flexible materialend pre-bent to expand into a funnel-shaped device when said lockingring 662 is removed. The special holding device in its funnel shapedexpandable state is shown in FIG. 40b . FIG. 40b further shows thespecial holding device 661 when placed in contact with the stomach wall12 of the human patient, after which the special holding member 661connects to the stomach wall 12, for holding the stomach wall 12. FIG.40c shows the instrument when the step of advancing a pushing rod 664from the elongated member 660 is performed. The pushing rod 664 pushesthe stomach wall 12 to create a cavity or pouch thereof. When thepushing rod 664 has pushed the stomach wall 12 to a desired position thespecial holding devices 661 moves towards the pushing rod 664 andthereby closes the cavity or pouch.

After the cavity or pouch has been created it needs to be sealed. FIG.40d shows the advancement of a suturing or stapling device 665 from theelongated member 660. The suturing or stapling device 665 is positionedin connection with the stomach wall 12 after which the suturing orstapling device 665 commences with the suturing or stapling of thestomach wall 12, creating a seal of stomach to stomach sutures orstaplers 14. Thereafter an inserting member 666 is advanced from theelongated member 660 and the special holding devices 661 are retracted.The inserting member 666 is adapted to insert a stretching device 10being inflatable, as described earlier in this application. After theinserting member 666 has been positioned in the cavity or pouch thestretching device 10 is inserted through the inserting member 666 andinto the cavity or pouch by means of a pressurized fluid or gas, or amechanical advancement member pushing said inflatable stretching device10 into the cavity or pouch. The insertion member 656 then inflates theinflatable stretching device with a fluid or gas and seals of the finalsection of the pouch using stomach to stomach sutures or staplers 14.The embodiment described explains the process of inserting an inflatablestretching device 10, however it is equally conceivable that thestretching device 10 is expandable by means of the stretching devicebeing made of an elastic material, FIG. 40 f shows the stretching device10 as the stretching device 10 is invaginated in the stomach wall 12, ina cavity or pouch sealed with stomach to stomach sutures or staplers 14.

FIG. 41a shows an instrument used in a method of engaging the stretchingdevice according to any of the embodiments of the application to thestomach wall 12. The instrument comprises an elongated member 670 whichis adapted to be flexible by means of a construction comprising multiplering shaped members, however it is equally conceivable that saidelongated member 670 is adapted to be flexible by means of saidelongated member 670 being made of a flexible or adjustable material.The elongated member 670 is inserted into the body and placed inproximity to the stomach wall 12 of the patient, from the insidethereof. A stomach penetrating member 672 is placed in the distal end ofthe elongated member 670, retractably fixated to a protective sleeve 673adapted to protect the tissue of the body from the sharp penetratingmember 672 or cutter 672 after the cutting operation has been performed.

FIG. 41b shows the instrument comprising the elongated member 670 afterthe cutting operation has been performed and the stomach penetratingmember or cutter 672 has been retracted into the protective sleeve 673.A guiding wire 671 is pushed through the elongated member 670, throughthe hole made in the stomach wall 12 and out through the abdomen andplaced on the inside of the patients skin, which is penetrated from theoutside to enable the guiding wire 671 to exit the abdomen. The guidingwire 671 can then be used to guide a conduit 18 or a lead attached tothe stretching device 10 being placed in the stomach from the insidethereof. The stretching device 10 with the conduit 18 or electrical leadbeing a stretching device 10 according to any of the embodiments of thisapplication. The guiding of the conduit 18 or electrical lead enablesthe attachment of the conduit 18 or electrical lead to a control unit 42placed subcutaneously in the patient from the outside of the abdomen.

FIG. 42 shows a flowchart describing the steps needed in an intraluminarmethod of inserting a device for stretching a portion of the stomachwall, the method comprises the steps of inserting an instrument into theesophagus 203 of the patient, step 1 a, inserting a device into thestomach of the patient through the esophagus 203 using the instrument,step 2 a, placing the device 10 in contact with the stomach wall 12,step 3 a, fixating the device to the stomach wall 12 such that thedevice can stretch a part of the stomach wall 12. The method describedcould further comprise the step of non-invasively regulating the deviceafter the placing of the device has been completed.

FIG. 43 shows a flowchart describing the steps needed in an abdominalmethod of inserting a device for stretching a portion of the stomachwall, the method comprises the steps of cutting a hole in the abdominalwall of said patient, step 1 b, dissecting an area around the stomach,step 2 b, placing said device in contact with the stomach, step 3 b andfixating direct or indirect through invagination of the stomach wall thedevice to the stomach wall such that the device can stretch a portion ofsaid stomach wall, step 4 b. The method described could further comprisethe steps of closing the hole in the abdomen using sutures or staplers14 and non-invasively regulating the device after the placing of thedevice has been completed.

Please note that any embodiment or part of embodiment or feature ormethod or associated system or part of system described herein may becombined in any combination.

1.-116. (canceled)
 117. A surgical kit for invaginating a medical deviceby an outside of a stomach wall of a patient, comprising: a stomachcutting instrument adapted to cut a hole through the stomach wall, astomach shaping instrument adapted to move a part of the stomach wall atthe hole to form a recess in the outside of the stomach wall, aninserting instrument adapted to insert the medical device through thehole and arrange the medical device in the recess such that an outersurface of the medical device rests against the outer surface of thestomach wall, and a fixating instrument adapted to assist ininvaginating the medical device in the recess, and a suturing instrumentadapted to seal the hole, wherein each of the stomach cuttinginstrument, the stomach shaping instrument, the inserting instrument andthe fixating instrument has a shape and size that allows it to beinserted into the stomach via an esophagus of the patient.
 118. Thesurgical kit according to claim 117, further comprising an opticalinstrument for viewing in the area of the stomach.
 119. The surgical kitaccording to claim 117, wherein the fixating instrument is adapted to beused for invaginating the medical device with stomach-to-stomachsutures.
 120. The surgical kit according to claim 117, wherein thefixating instrument is adapted to be used for invaginating the medicaldevice with stomach-to-stomach staplers.
 121. The surgical kit accordingto claim 117, wherein said inserting instrument is adapted to be usedfor inserting the medical device in a non-inflated state through thehole in the stomach wall.
 122. The surgical kit according to claim 117,further comprising an elongated member, wherein the stomach cuttinginstrument is provided at a proximal end of the elongated member. 123.The surgical kit according to claim 117, wherein the stomach shapinginstrument comprises an expandable member adapted to be expanded on theoutside of the stomach wall and assist in the forming of the recess.124. The surgical kit according to claim 123, wherein the expandablemember is an inflatable balloon.
 125. The surgical kit according toclaim 117, further comprising a holding instrument adapted to abut aninside surface of the stomach wall so as to provide a guiding supportfor the stomach shaping instrument and the inserting member.
 126. Thesurgical kit according to claim 117, wherein the stomach shapinginstrument comprises a vacuum sucking instrument adapted to suck thestomach wall to form the recess.
 127. The surgical kit according toclaim 126, wherein the vacuum sucking instrument comprises a pluralityof openings adapted to suck the stomach wall towards the stomach shapinginstrument.
 128. The surgical kit according to claim 126, wherein thevacuum sucking instrument is shaped as a tube.
 129. The surgical kitaccording to claim 117, further comprising at least one clampinginstrument adapted to hold an opening of the recess substantially closedby clamping together portions of the stomach wall at said opening. 130.The surgical kit according to claim 117, further comprising at least oneclamping instrument adapted to be placed at the opening of the recess toallow subsequent suturing of the opening.
 131. The surgical kitaccording to claim 117, further comprising an inflation instrument forinflating the medical device when it has been placed in the recess. 132.The surgical kit according to claim 117, wherein the inserting membercomprises an outer sleeve and an inner sleeve which can be displacedlongitudinally relatively to the outer sleeve, and wherein the stomachcutting instrument is formed as a distal end of the inner sleeve. 133.The surgical kit according to claim 132, further comprising a pistonmovable arranged within the inner sleeve, wherein the piston is adaptedto push the medical device through the hole in the stomach wall. 134.The surgical kit according to claim 117, configured to invaginate amedical device being a movement restriction device for treatment ofreflux.
 135. The surgical kit according to claim 117, configured toinvaginate a medical device being a volume filling device for treatmentof obesity.